Consent for Research Study RESCUE: Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations ACRIN 4701

Consent for Research Study

RESCUE: Randomized Evaluation of Patients with Stable Angina

Comparing Utilization of Diagnostic Examinations

ACRIN 4701 www.rescuetrial.org

DISCLAIMER: “RESCUE” stands for Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations. RESCUE is the acronym for the study title and does not indicate any health benefit related to your decision to participate in the trial.

• The main goals of this study are:– To compare two different ways to diagnose the

cause of your chest pain using :• Nuclear medicine cardiac stress test (standard

diagnostic imaging test)• Coronary Computed Tomography Angiography (CCTA

also known as Cardiac CT) – To see if medication prescribed based on the

imaging results can safely prevent or delay the need for an invasive procedure for your heart disease

Purpose of Study


Purpose of Study

• This study will compare CCTA and nuclear medicine cardiac stress test results, to decide on the use of medication and lifestyle change

• This study will also look at the well being of patients who had CCTA to diagnosis CAD to the well being of patients who had the nuclear stress (SPECT MPI) test

• About 4300 people from 80 hospitals around the world will participate


About Angina• Angina is chest pain or discomfort that occurs when an area of your heart muscle doesn't get enough oxygen-rich blood• Angina may feel like pressure or squeezing in your chest or in your shoulders, arms, neck, jaw, or back• Angina usually is a symptom of coronary artery disease (CAD)


Participation

• You are being asked to join the study for up to two years (24 months)

• If you take part in this study, you will have one of two diagnostic tests and your treatment will be determined by your diagnosis.

• After one year, you may be asked to complete questionnaires about your health and quality of life.


Participation• If you are diagnosed with heart disease you will be contacted by the research staff a minimum of 4 times – at 2 weeks, 2 months, 6 months and 12 months.• If you are not diagnosed with heart disease, you will be contacted by research staff a minimum of 2 times – at 6 and 12 months. • In either case, you may also be contacted again at 18 and 24 months.


When you join the study

• We will ask you to provide your contact information, including mailing address, and the name of a person we can contact who knows about your heart health should you be unavailable.

• You will be asked to complete 2 questionnaires that describe your health and quality of life.


Diagnosis

• If you decide to join the trial, you will be randomly assigned to either:– Group A CCTA - takes pictures (also called

images) of your heart without having to put any tubes in the blood vessels near your heart.

– Group B Nuclear medicine cardiac stress test – monitors how your heart works during exercise or using medication to excite the heart.

ACRIN 4701

Treatment

• Depending on your diagnosis, your study and treating doctors have agreed to a specific treatment approach for this trial. – You may be discharged from the hospital with a

prescription for medication and lifestyle changes or,

– You may need an invasive procedure for your disease.


Follow-up Questionnaires

• 6 and 12 months after you join the trial, you will be asked some questions about your heart and other health, treatment, who has been treating you and where, and what medical help you may have gotten

• 12 months after you join the trial, you may receive by mail the same two questionnaires from the start of the study asking about your health and quality of life


Follow-up Questionnaires

• At 18 and 24 months after you join the trial, you may be called again by the research staff and asked about your heart and other health and treatment

• Depending on how you answer follow-up questions about your heart health and treatment, the study staff may need to look at your medical records from other facilities outside of this one.


Risks Associated With Participation

• You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects.

• Talk to your doctor or nurse about any side effects that you have while taking part in the study


Benefits of Participation

• Taking part in this study may or may not make your health better. The information from this study will help doctors: – Decide on the best testing and treatment for people

with chest pain in the future– Help lower the need for invasive procedures for

some patients – Show the value of medical treatment before an

invasive procedure


Choosing Participation

You may choose not to take part in this study. If you choose not to participate, there will be no penalty and your treatment/medical care

will not be affected. Your treating doctor can tell you the different available treatments for

your chest pain or heart condition.


Patient Confidentiality

• We will do our best to make sure that your personal information will be kept private.

• All personal information will be removed and replaced with a unique identifying number to protect your identity.


Cost of Participation

• You will receive no payment for taking part in this study.

• You will not be responsible for the costs of any exams or treatments that are considered part of the study and not part of standard care, such as the CCTA if you are randomly assigned to Group A.


Cost of Participation

• You and/or your health insurance will be charged for any portion of your care that is considered standard care (that is, if these expenses would have happened even if you were not in the study), such as the nuclear medicine cardiac stress test used in Group B

• You may be responsible for co-payments and deductibles that are standard for your insurance coverage.

• You and/or your insurance company will be charged for continuing medical care and/or hospitalization, including emergency medical care.


In Case of Injury• If injured while on the study it is important that you tell your study doctor• In the case of medical emergency, injury, or illness during this study, emergency medical treatment is available but will be provided at the usual charge. You and/or your insurance will be responsible for the cost of the medical care of that illness or injury.


Your Rights• Taking part in this study is your choice. • You may choose not to take part in the study. • If you decide to participate, you are free to leave the study at any time. • No matter what decision you make, there will be no penalty to you, and you will not lose any of your regular treatment and medical care options now or in the future. You can still get your medical care from our institution.


For questions

• Regarding the research study:– Contact the study doctor or research associate

• Regarding patients’ rights:– Ask your study doctor or research associate who

you should contact at their Institutional Review Board (IRB)

For more information about the study and other helpful resources please visit our website:

www.rescuetrial.org


http://www.rescuetrial.org/

Documents

Consent for Research Study RESCUE: Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations ACRIN 4701