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Supplemental Appendix
Table of Contents
AngelMed Guardian Product Specifications.......................................................................2Detailed Description of the Confirmation of Thrombotic Coronary Occlusion..................3Figure S1 Expanded Analyses Group Membership.............................................................4Description of Expanded Analyses Development and FDA Submission ...........................5Table S1a Q-Wave Patterns that Qualified as a “New Q-Wave” Based upon a Single Baseline ECG.....................................................................................................7 Table S1b Q-Wave Patterns that Qualified as a “New Q Wave” Based upon Assessment of Two Baseline ECGs.......................................................................................7 Figure S2 Arrival delays from Guardian detection for all confirmed thrombotic events during the 0 to 6 month randomized period.........................................................8Table S2 Number of Events in each Component of the Primary Efficacy Endpoint..........9Table S3 Positive Tests Confirming Occlusive Events by Group during the Randomized Period............................................................................................10 Table S4 Incidence of New Q-Wave MI at 6 Months Follow-Up ECG............................11Table S5 Outcomes in Silent MI Risk Subgroup...............................................................12Table S6 Death through 6 months.....................................................................................13Table S7 Co-Primary Endpoint of Expanded Analysis: PPV and FPR.............................14Table S8 Positive Predictive Value during the 6 Month Randomized Period and the Crossover Period...........................................................................................15Table S9 Other Medical Conditions Detected...................................................................16Appendix A – Enrolling Sites............................................................................................17
1
AngelMed Guardian Implantable Medical Device (IMD) Product Specifications
Item Specification
Dimensions Height (Vertical) Width (Horizontal) Depth
2.10 in (53 mm)2.13 in (54 mm)0.40 in (10 mm)
Weight 1.1 oz (32 grams)Volume 23.4 cm3
2
Confirmation of a Thrombotic Coronary Occlusion Event
For patients with a symptom- to-door time > 2 hours, if no new Q-wave is present, a thrombotic
coronary event was confirmed by the presence of any of the following:
1. ST elevation via 12 lead ECG as determined by blinded, independent Core Lab Review (Duke
Clinical Research Institute ECG Core Lab)
2. If the Guardian System detects a rapidly progressive ST shift event and a thrombotic coronary
occlusion event is not confirmed via a 12 Lead ECG, then a thrombotic coronary occlusion event
may be confirmed via any of the following:
a) Elevated enzymes/biomarkers (CK, CK-MB, or Troponin) per the standard of care at
treating hospital, e.g., above the upper limit of normal and considered within the “necrosis
range” within 24 hours of the onset of ischemic discomfort.
b) A positive stress test
c) Angiography via the presence of any of the following findings: TIMI flow grade < 3, a
corrected TIMI frame count > 40, a TIMI myocardial perfusion grade of 0 or 1, a new
thrombus, a new ulcer, a new distal embolus with an abrupt cutoff, a new dissection or a new
wall motion abnormality as assessed by an independent angiographic core Lab (PERFUSE
Core Lab, Beth Israel Deaconess Medical Center, Harvard Medical School).
3
Figure S1
Expanded Analyses Group Membership
4
Description of Expanded Analyses Development and FDA Submission
Enrollment of the first ALERTS trial subject occurred on December 12, 2008. Enrollment
was capped at 1020 subjects and the final subject completed the 6-month randomization period
on December 19, 2013. Following trial completion a modular premarket approval (PMA) was
submitted to the Food and Drug Administration (FDA):
Module 1 (Pre-Clinical Testing) – March 27, 2014
Module 2 (Quality Manufacturing) – May 16, 2014
Module 3 (ALERTS Trial Clinical Results) – March 16, 2015
An FDA Advisory Panel was convened on March 16, 2016 and recommended against approval
of the device at the conclusion of the meeting. The sponsor received a letter from the FDA on
May 11, 2016 indicating that the sponsor needed to address issues raised at the Advisory Panel to
obtain PMA approval.
The sponsor and FDA met in June of 2016 to review a proposal for a new statistical
analysis plan using post-randomization clinical data previously collected in accordance with the
ALERTS protocol, but not yet adjudicated or analyzed. This post-randomization data became the
basis for the expanded analyses which compared control subjects with alerting turned off
(ALARMS OFF) to ALARMS ON subjects, which included both treatment and control subjects
with alerting turned on. Further, the FDA proposed pre-specification of new clinical endpoints, a
new clinical adjudication process, a new adjudication committee, and a new statistical analysis
prior to any data review to ensure that results met the appropriate level of scientific rigor.
The following steps were performed:
1. A new clinical events committee (CEC) composed of four independent practicing
cardiologists with no previous exposure to the ALERTS trial was assembled. A new
5
clinical event adjudication charter was utilized which pre-specified universal definitions
approved by the FDA for myocardial infarction (MI), unstable angina (UA), and
included two new MI definitions that reflected the novel nature of ACS detection
(Aborted MI and Silent MI). At least 3 cardiologists independently adjudicated each
event and a pre-specified tie breaking procedure was implemented.
2. A new set of pre-specified clinical efficacy endpoints were defined and associated
statistical hypotheses were developed. The FDA recommended the primary endpoints
should focus on the accuracy of device detections including positive predictive value and
false positive rate. Secondary endpoints for asymptomatic device detections and an
overall profile of symptom and alarm to door times were also agreed upon.
3. A new process for managing interpretation of false negative data was defined.
Submission of long term safety data (including explant related adverse events) and patient
alarm compliance data was agreed upon. The protocol and detailed statistical analysis plan was
jointly approved by the sponsor and FDA prior to CEC adjudication and analyses. The results
were used to develop an amendment to the PMA submission which was submitted on May 5,
2017 and the PMA was approved on April 9, 2018.
6
Table 1a
Q-wave patterns that qualified as a “New Q Wave” Based Upon a Single Baseline ECG
Q-Wave Patterns to Qualify for “New Q-Wave MI” with a Single Baseline
Baseline at Randomization 1 Mo. Visit 3 Mo. Visit 6 Mo. Visit
Absent Present Present Present
Absent Absent Present Present
Absent Absent Absent Present
Table 1b
Q-wave patterns that qualified as a “New Q Wave” Based Upon Assessment of Two Baseline
ECGs
Q-Wave Patterns To Qualify for “New Q-Wave MI” with Dual Baselines
Baseline Pre-Implant Baseline at Randomization 1 Mo. Visit 3 Mo. Visit 6 Mo. Visit
Absent Absent Present Present Present
Absent Absent Absent Present Present
Absent Absent Absent Absent Present
7
Figure S2
Arrival delays from Guardian for all confirmed thrombotic events during the 0 to 6 months randomized period
Data based on time from ST shift detection to patient arrival with single positive test (enzymes, ECG, stress test, angio, etc.) as adjudicated by an independent events committee
8
Table S2
Number of Events in each Component of the Primary Efficacy Endpoint
Control Group(N=456)
Treatment Group(N=451)
Posterior Probability
N n (%) N n (%)Cardiac or Unexplained Death
447 1 (0.2%) 441 3 (0.7%)New Q-wave MI (Dual Baseline)
427 13 (3.0%) 420 7 (1.7%)Time-to-Door >2 Hours
Look-back Window
7-Day 446 8 (1.8%) 439 4 (0.9%)90-Day 446 17 (3.8%) 439 4 (0.9%)
Composite Primary Endpoint (Dual Baseline)Look-back Window
7-Day 428 20 (4.7%) 423 13 (3.1%) 0.883390-Day 428 28 (6.5%) 423 13 (3.1%) 0.9908
9
Table S3
Positive Tests Confirming Occlusive Events by Group during the Randomized Period
Number of Tests
Tests Confirming Event Control Group (N=18)
Treatment Group(N=34)
Cardiac Enzymes ECG Angiograph
yStress Test
4 X X X X 0 1 (2.9%)
3 X X X 2 (11.1%) 1 (2.9%)X X X 1 (5.6%) 3 (8.8%)
2
X X 0 6 (17.6%)X X 2 (11.1%) 4 (11.8%)
X X 1 (5.6%) 5 (14.7%)X X 1 (5.6%) 1 (2.9%)
X X 0 3 (8.8%)
1
X 4 (22.2%) 3 (8.8%)X 5 (27.8%)* 3 (8.8%)
X 1 (5.6%) 2 (5.9%)X 1 (5.6%) 2 (5.9%)
This table includes all confirmed occlusive events that occurred during the randomized period used to calculates time-to-door and late arrival. This table includes events with detection-to-door time <2 hours.*Includes 4 events with ST depression or morphological T wave changes, which were not included in the protocol.
10
Table S4
Incidence of New Q-wave MI on 6 Month Follow-up ECG
Baseline ECG Control Group(N=427)
Treatment Group
(N=420)
Difference(Treatment -
Control)95% BCI
Posterior Prob Pr(RT < RC |
data)
Single Baseline 14 (3.3%) 10 (2.4%) (-3.24%, 1.42%) 0.7783Dual Baseline 13 (3.0%) 7 (1.7%) (-3.57%, 0.72%) 0.9015
11
Table S5
Outcomes Among Silent MI Risk Subgroup
Control Group
(N=243)
Treatment Group
(N=222)
Posterior Prob Pr(RT < RC |
data)Single Baseline ECG
New Q-wave 12 (4.9%) 6 (2.7%) 0.8867New Q-wave or Late Arrival (7-day) 14 (5.8%) 8 (3.6%) 0.8542New Q-wave or Late Arrival (90-day) 17 (7.0%) 8 (3.6%) 0.9446
Dual Baseline ECGNew Q-wave 11 (4.5%) 4 (1.8%) 0.9470New Q-wave or Late Arrival (90-day) 16 (6.6%) 6 (2.7%) 0.9471
The silent MI risk subgroup was composed of subjects who met at least one of the following criteria: diabetic, women over the age of 65, history of prior silent ischemia.Posterior probability threshold was not met for any endpoint
12
Table S6
Death Through 6 Months
Control Group(N=451)
Treatment Group(N=456)
Cardiovascular 1 3Non-cardiovascular 2 0Total 3 (0.67%) 3 (0.66%)
13
Table S7
Co-Primary Endpoint of Expanded Analysis: Positive Predictive Value and False Positive Rate
ALARMS OFFSymptoms Only
ALARMS ONWith or Without Symptoms p-value
Emergency Visits 181 345True Positive 33 89False Positive 148 256PPV 18.2% 25.8% 0.031*FPR (FP/patient year) 0.678 0.164 <0.001**
*One-sided Fisher’s exact test for superiority (significance level = 0.025)**Generalized linear model based on a Poisson distribution and the canonical log link functionPPV = positive predictive value, FPR = false positive rate
14
Table S8
Positive Predictive Value during the 6 Month Randomized and the Crossover Period
6 Month Randomization Period Crossover PeriodTreatment Group (ALARMS ON)with or without
symptoms
Control Group (ALARMS OFF)
Control Group (ALARMS ON) with or without
symptomsEmergency Visits 102 181 125True Positives 28 33 34False Positives 74 148 91PPV 27.5% 18.2% 27.2%
During the 6 month randomized period the treatment group had alarms turned on and the control group had alarms turned off. Data on the control group after the alarms were turned after the completion of the randomized period (crossover period) are also presented.PPV = Positive Predictive Value
15
Table S9
Other Medical Conditions Detected by Guardian Alerts
Medical Condition Detected Number of Events Number of Subjects(N = 910)
Anemia 12 11 (1.2%)Atrial Fibrillation 33 26 (2.9%)Bradycardia 18 17 (1.9%)New Onset Bundle Branch Block 9 8 (0.9%)Hypokalemia 9 8 (0.9%)Tachycardia 25 19 (2.1%)Transient Heart Block 2 2 (0.2%)Total 108 79 (8.7%)
16
Appendix A - Enrolling Sites
Germany
Albert Ludwig University of FreiburgPrincipal Investigator: Manfred Zehender, Prof. Dr.Research Coordinator: Gudrun Heinrichs
The United States
Alabama
Huntsville Hospital / Heart Center ResearchPrincipal Investigator: Jay Dinerman, MDResearch Coordinator: Lisa Eskridge
Arizona
Banner Good Samaritan HospitalPrincipal Investigator: Asish Pershad, MDResearch Coordinator: Elizabeth Russo, RN
Banner Heart HospitalPrincipal Investigator: Andrew Kaplan, MDResearch Coordinator: Heidi Terry, MN, RN, CCRC
Southwest Heart GroupPrincipal Investigator: Brenda C. Peart, MDResearch Coordinator: Ken Peart, CCRC
California
California Clinical Research FoundationPrincipal Investigator: Joseph Ghazal, MDResearch Coordinator: Murali Gali, MD
Huntington Memorial HospitalPrincipal Investigator: Mayer Rashtian, MDResearch Coordinator: Samia Solh, RN
John Muir Clinical Research CenterPrincipal Investigator: Ayman Hosny, MDResearch Coordinator: Suzanne Clements, RN, BSN, CCRC
17
Long Beach Memorial Medical CenterPrincipal Investigator: John Messenger, MD Serge Tobias, MDResearch Coordinator: Kim West, ACNPC
Orange County Heart Institute and Research CenterPrincipal Investigator: Kelly Tucker, MDResearch Coordinator: Karena D La Mora, CRC
Radiant ResearchPrincipal Investigator: Sanjay Dhar, MDResearch Coordinator: Sabine Ucik, CCRC
Salinas Valley Memorial HospitalPrincipal Investigator: Robert Wlodarczyk, DOResearch Coordinator: Terri Nielsen RN, BSN, CCRC
Sutter Memorial HospitalPrincipal Investigator: David Roberts, MDResearch Coordinator: Deborah Holmes-Rees, RN
University of California – Davis Medical CenterPrincipal Investigator: Reginald Low, MDResearch Coordinator: Lisa Ayer-Rand RN, BSN, CCRP
Florida
Bay Pines VA Healthcare SystemPrincipal Investigator: Philip Stromquist, MDResearch Coordinator: Hafida Nekach, MD, CCRC
Daytona Heart GroupPrincipal Investigator: Glenn Rayos, MDResearch Coordinator: Terry Purcell
East Coast Institute for Research – Flagler HospitalPrincipal Investigator: Ferris George, MDResearch Coordinator: Rebecca Rossenwasser, PharmD, CCRP
Edgewater Medical Research, Inc.Principal Investigator: Eric Lo, MDResearch Coordinator: Tina Blount, CRC
Florida Hospital-Pepin Heart InstitutePrincipal Investigator: Charles R. Lambert, MDResearch Coordinator: Elizabeth Szymanski, RN, MSN
18
Holy Cross HospitalPrincipal Investigator: Rishi Anand, MDResearch Coordinator: Cheryl Langer
Mercy Research InstitutePrincipal Investigator: Manual Mayor, MDResearch Coordinator: Jose Quesada
New Phase Clinical TrialsPrincipal Investigator: Juan Carlos Londono, MDResearch Coordinator: Lourdes Gonzalez
North FL / South GA VA Health SystemPrincipal Investigator: Mark Panna, MDResearch Coordinator: Susan Stinson
University of Miami Health SystemsPrincipal Investigator: Claudia A. Martinez, MDResearch Coordinator: Bonni Lang, RN
University of South FloridaPrincipal Investigator: Philip Rogal, MDResearch Coordinator: Jessica Walker
Georgia
Medical Center, Navicent Health (formerly Medical Center of Central Georgia)Principal Investigator: Mark Dorogy, MDResearch Coordinator: Carrie Knott, RN, BSN, MPH, CCRC
Piedmont HospitalPrincipal Investigator: Andrew Wickliffe, MDResearch Coordinator: Kristi Picardi
Illinois
Advocate Medical GroupPrincipal Investigator: Barry Laskoe, DOResearch Coordinator: Gabriella Fini
Northwestern Bluhm Cardiovascular Institute Principal Investigator: Dan J. Fintel, MDResearch Coordinator: Elonia Martin, BA
19
Prairie EducationPrincipal Investigator: Ziad Issa, MDResearch Coordinator: Michael Diefenback
Indiana
Heart Center of Lake CountyPrincipal Investigator: Andre K. Artis, MDResearch Coordinator: Kimberly Armstrong, RN BSN, MBA
Medical Consultants, PCPrincipal Investigator: Bruce M. Graham, MDResearch Coordinator: Sherry Adair, RN
Northern Indiana Research AlliancePrincipal Investigator: Sree Karanam, MDResearch Coordinator: Tracy Miller
IU Health Bloomington (formerly Premier Healthcare, LLC)Principal Investigator: John Strobel, MDResearch Coordinator: Amber Brooks-Wolfe, LPN, CCRC
Kentucky
Baptist Health LexingtonPrincipal Investigator: Paula Hollingsworth, MDResearch Coordinator: Julie Ayers, RN, BSN
Louisiana
Heart Clinic of HammondPrincipal Investigator: Ghiath Mikdadi, MDResearch Coordinator: Cheryl Clavier Firmin, AAS, CRC
Innovative Medical ResearchPrincipal Investigator: Dale Presser, MDResearch Coordinator: Candice Crespo
Louisiana Heart CenterPrincipal Investigator: Bruce J. Iteld, MDResearch Coordinator: Brandy Ocman, RN
20
Maryland
MedStar Health Research Institute / Good Samaritan HospitalsPrincipal Investigator: Jerald Insel, MDResearch Coordinator: Cynthia Lynn Yashinski, BA, CCRC
Suburban HospitalPrincipal Investigator: Gregory Kumkumian, MDResearch Coordinator: Ann Greenberg, RN
University of Maryland Medical CenterPrincipal Investigator: Peter Reyes, MDResearch Coordinator: Lori Black
Washington Adventist HospitalPrincipal Investigator: Sean Beinart, MDResearch Coordinator: Melissa Ramey
Michigan
Borgess Heart InstitutePrincipal Investigator: Vishal Gupta, MD; Glenn Kabell MDResearch Coordinator: Sandy Wilson
Cardiac & Vascular Research Center of Northern MichiganPrincipal Investigator: Harry T. Colfer, MDResearch Coordinator: Jennifer LaLonde, RN, BSN, CCRC
Cardiology Consultants of East MichiganPrincipal Investigator: Abdul Alawwa, MDResearch Coordinator: Tina Marie Conyer
Detroit Clinical Research Center – GrodmanPrincipal Investigator: Robert Grodman, DOResearch Coordinator: Candice Shallal, BS
DMC Cardiovascular Institute at Harper-Hutzel HospitalPrincipal Investigator: Theodore Schreiber, MDResearch Coordinator: Marybeth McCarthy
Genesys Regional Medical CenterPrincipal Investigator: Marc Silver, MDResearch Coordinator: Sandy Watt, RN
21
McLaren Bay RegionPrincipal Investigator: Daniel Taehee Lee, MDResearch Coordinator: Colette Quart, RN, BSN, CCRC
Sparrow Clinical Research InstitutePrincipal Investigator: Guarav Dhar, MDResearch Coordinator: Heidi Taylor, RN, BSN
Spectrum HealthPrincipal Investigator: David Wohns, MDResearch Coordinator: Karen Postema
Minnesota
Mayo ClinicPrincipal Investigator: Yong-Mei Cha, MDResearch Coordinator: Jacqueline Wanek, RN
New Jersey
Jersey Shore University Medical CenterPrincipal Investigator: Charles Koo, MDResearch Coordinator: Anne Marie DeToro, RN, BS, CCRC
Lourdes Cardiology ServicesPrincipal Investigator: Devender Akula, MD; Darius Sholevar, MDResearch Coordinator: Maura Kendall
St. Michaels Medical CenterPrincipal Investigator: Abbas Shehadeh, MDResearch Coordinator: Raymond Monel, MS, RC, C-HIR-Pro
University of Medicine and Dentistry NJPrincipal Investigator: Tudor Vagaonescu, MDResearch Coordinator: Erin Squindo, LPN
New York
Albany Associates in CardiologyPrincipal Investigator: Eric Roccario, MDResearch Coordinator: Peggy Sue Shaummann-Boyle, RN
Buffalo Heart GroupPrincipal Investigator: A.R. Zaki Masud, MD, Research Coordinator: Jodi Skinner, RN, CCRP
22
Cardiology Group of Western New York, P.C.Principal Investigator: Salvatore Calandra, MDResearch Coordinator: Kyle Mann
Columbia University Medical CenterPrincipal Investigator: Tamim Nazif, MDResearch Coordinator: Treena Williams
Mercy Hospital of BuffaloPrincipal Investigator: Irfan Khan, MD; Michael Hong, MDResearch Coordinator: Theresa Giambra, RN, CCRP
Stony Brook University Medical CenterPrincipal Investigator: Eric Rashba, MDResearch Coordinator: Jennifer Intravaia
SUNY Downstate Medical CenterPrincipal Investigator: John Kassotis, MDResearch Coordinator: Ann Harris, NP
North Carolina
REX HealthcarePrincipal Investigator: Sameh K. Mobarek, MDResearch Coordinator: Rebecca Palermo
Ohio
Cardiovascular Research CenterPrincipal Investigator: Ameer Kabour, MDResearch Coordinator: Michelle Hickam, RN
Good Samaritan HospitalPrincipal Investigator: Gary Fishbein, MDResearch Coordinator: Annie Neff, RN, BSN
University of ToledoPrincipal Investigator: Thomas Schwann, MDResearch Coordinator: Terri Kozi
Oklahoma
South Oklahoma Heart Research, LLCPrincipal Investigator: Naeem K. Tahirkheli, MDResearch Coordinator: Adriana Santos, CCRC
23
Pennsylvania
Allegheny-Singer Research InstitutePrincipal Investigator: David Lasorda, MDResearch Coordinator: Kenneth Rayl
Donald Guthrie Foundation for Education & ResearchPrincipal Investigator: Govindarajan Venkatesh, MDResearch Coordinator: Donna Tyburczy, RN, BSN, CCRP
Drexel University College of MedicinePrincipal Investigator: John M. Fontaine, MDResearch Coordinator: Shawn Cone
Geisinger Medical CenterPrincipal Investigator: Jess Oren, MDResearch Coordinator: Susan Kilbride
Lancaster General HospitalPrincipal Investigator: Seth J. Worley, MDResearch Coordinator: Kay M. Knepper, RN
Penn State Hershey Medical CenterPrincipal Investigator: Ian Gilchrist, MDResearch Coordinator: Kevin Gardner
St. Mary Medical Center Research InstitutePrincipal Investigator: Rakesh Shah, MDResearch Coordinator: Marci Petrino, BSN, CCRP
Cardiac Diagnostic Associates/York HospitalPrincipal Investigator: Brian Schuler, MDResearch Coordinator: Barb Delio-Cox
South Carolina
AnMed HealthPrincipal Investigator: Satish Surabhi, MDResearch Coordinator: Charles A Davis, RN, BSN
Greenville Hospital SystemPrincipal Investigator: Arthur Eberly III, MDResearch Coordinator: Donita O’Hearn, RN, BSN, CCRP
24
Tennessee
St. Thomas Research InstitutePrincipal Investigator: George H. Crossley III, MDResearch Coordinator: Danielle Buchanan, RN
The Stern Cardiovascular CenterPrincipal Investigator: Frank McGrew, MDResearch Coordinator: Brian Dragutsky
Turkey Creek Medical CenterPrincipal Investigator: Malcolm Foster, MDResearch Coordinator: Beth Polk, RN, CCRC
Texas
Cardiology Center of Amarillo (Clinical Tex Research, LLC)Principal Investigator: Sammy Lane Cox, MDResearch Coordinator: Amy Tucker, CRC
Scott and White Memorial HospitalPrincipal Investigator: Peter Cheung, MDResearch Coordinator: Wanda Fikes, RN
Tyler Cardiovascular Consultants, PAPrincipal Investigator: Robert Carney, MDResearch Coordinator: Greg Murphy
West Houston Area Clinical Trial Consultants – HaasPrincipal Investigator: Philip Clay Haas, DOResearch Coordinator: Jawad Ashour
West Houston Area Clinical Trial Consultants, LLCPrincipal Investigator: Amir Kashani, MDResearch Coordinator: Neil Schmitz
Virginia
Bayview Physician Services (formerly Cardiovascular Associates, LTD)Principal Investigator: John Griffin, MDResearch Coordinator: DeAnne Grove, BSN, RN, CRC
Cardiology Associates of FredericksburgPrincipal Investigator: Ashok Talreja, MDResearch Coordinator: Mary Lou Hollingshead, RN
25
Inova Cardiology Ambulatory Research (formerly Cardiovascular Associates of Virginia)Principal Investigator: Shahram Yazdani, MDResearch Coordinator: Kathleen Morgan
Riverside Regional Medical CenterPrincipal Investigator: Allan Murphy, MBBSResearch Coordinator: Virginia Oehmann
Sentara Cardiovascular Research Institute Principal Investigator: Allen Ciuffo, MDResearch Coordinator: Tina Calayo
Washington
Swedish Medical Center / Cardiovascular ResearchPrincipal Investigator: John Peterson II, MDResearch Coordinator: Inger Rasmussen, BA, CCRC
Washington DC
Washington Hospital CenterPrincipal Investigator: Ron Waksman, MDResearch Coordinator: Michelle Deville
26