Active not recruitingOBSERVATIONAL

PRE-DETERMINE Cohort Study

This study, called PRE-DETERMINE, is for people who have had problems with their heart arteries, such as a previous heart attack, or have slightly weakened heart muscle (left ventricular dysfunction). Doctors are collecting information, blood samples, and heart tracings (ECGs) from these patients. The main goal is to discover if certain markers in blood or on ECGs can help predict who is at higher risk of experiencing a sudden, life-threatening heart rhythm issue, compared to other causes of death. Finding these markers could lead to better ways to identify and protect those most at risk, potentially making treatments like pacemakers (ICDs) more effectively used.

At a glance

Status

Active not recruiting

Sponsor

Brigham and Women's Hospital

Enrolment target

5,764

Start

01 Jul 2007

Estimated completion

01 Nov 2026

Coronary Artery Disease Left Ventricular Dysfunction Sudden Cardiac Death

What is this study about?

The PRE-DETERMINE study is looking into ways to better understand and predict serious heart problems. It focuses on individuals who have coronary artery disease, which means the blood vessels supplying the heart are narrowed or blocked. These individuals either have a history of a heart attack or have a heart muscle that doesn't pump quite as strongly as it should, though not severely.

The main aim is to find out if certain markers in your blood, or signals picked up by an electrocardiogram (ECG) – which measures your heart's electrical activity – can help doctors predict who might be at risk of a sudden, unexpected heart stoppage, known as sudden cardiac death. By identifying these markers, doctors hope to get better at predicting who needs extra care, potentially helping to prevent these serious events.

Ultimately, if they can find clear signs that point to a higher risk of these sudden heart rhythm problems, it could mean that people at risk could be identified more easily and affordably. This could improve how certain devices, like implantable cardioverter-defibrillators (ICDs), are used, ensuring they go to those who will benefit most, and deepening our understanding of why sudden cardiac death happens.

Key takeaways

Focuses on people with heart artery disease or weakened heart muscle.
Aims to find blood or ECG markers to predict sudden heart problems.
Could lead to better prediction and prevention of serious heart events.
Involves providing health information, blood samples, and ECGs.
Participants are followed up by mail/phone over time.
Results could help improve the use of life-saving heart devices.

Who may be eligible?

This study is open to adults aged 18 or over. To be considered, you generally need to have a history of coronary artery disease, which means your heart's blood supply has been affected, for example, by narrowed arteries or a previous heart attack. You would also have some degree of heart muscle weakness, specifically that your heart's main pumping chamber (the left ventricle) doesn't pump blood quite as strongly as it could, but usually not severely.

More specifically, if you have had a heart attack in the past, or if tests show your heart's pumping ability (called LVEF) is between 35% and 50%, you might be eligible. There are also specific rules if your heart's pumping ability is slightly lower, between 30% and 35%, as long as you haven't had certain fast heart rhythms before.

You would not be able to join if you have already had a sudden heart stoppage, or a type of fast, dangerous heart rhythm called sustained VT, either naturally or during special heart tests.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with coronary artery disease or had a heart attack?
Has your heart's pumping ability (LVEF) been measured between 35% and 50%?
Have you NEVER had a sudden heart stoppage or a previously diagnosed dangerous fast heart rhythm (sustained VT)?

Answer every question to see your result.

What does participation involve?

If you join the PRE-DETERMINE study, your involvement would include providing information about your medical history, lifestyle, and current medications. You would also have an electrocardiogram (ECG) and a blood sample taken at the beginning of the study. Some participants might also have a special heart scan called a contrast-enhanced MRI. After this initial stage, the study team will keep in touch with you, usually by mail or phone, every six months. They will send questionnaires to ask about any new heart events, changes in your health, or if you've had an ICD fitted or received any treatments from it. If you don't respond, they'll call you. The study aims to follow participants centrally over a period of time to track their health and any outcomes.

Potential risks and benefits

Participating in this study might not directly benefit your health but could help doctors learn more about heart conditions and how to prevent serious problems in the future, which could benefit others. The risks involved are generally low and would include the usual discomfort of a blood test, and potentially the time taken to complete questionnaires and answer phone calls. If you have an MRI, there are standard, minor risks associated with that procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (90)

Alaska Heart Institute
Verified postcode
Anchorage, United States
Phoenix Heart, PLLC
Verified postcode
Glendale, United States
Cardiovascular Consultants
Verified postcode
Phoenix, United States
Beaver Medical Group/Clinical Care Research
Verified postcode
Banning, United States
Memorial Health System
Verified postcode
Colorado Springs, United States
Colorado Heart and Vascular
Verified postcode
Denver, United States
Bay Area Cardiology Associates, P.A.
Verified postcode
Brandon, United States
University of Florida - Gainsville
Verified postcode
Gainesville, United States
Reliable Clinical Research
Verified postcode
Miami, United States
Mount Sinai Medical Center
Verified postcode
Miami Beach, United States
Florida Hospital
Verified postcode
Orlando, United States
Orlando Regional Medical Center
Verified postcode
Orlando, United States

Common questions

What is Coronary Artery Disease?

It's when the main blood vessels that supply your heart become narrowed or blocked, usually by fatty deposits. This can reduce blood flow to your heart muscle.

What is Left Ventricular Dysfunction?

This means the main pumping chamber of your heart (the left ventricle) isn't pumping blood as strongly as it should, leading to symptoms like tiredness or breathlessness.

What is an ECG?

An ECG (electrocardiogram) is a simple, painless test that records the electrical activity of your heart. It helps doctors check your heart's rhythm and overall health.

What is "Sudden Cardiac Death"?

This is when the heart suddenly stops beating effectively, often due to an unexpected, very fast or irregular heart rhythm. It's a serious medical emergency.

Will I receive new treatment in this study?

No, this study is observational, meaning doctors are just gathering information about your health. You won't receive experimental treatments or medications as part of it.