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Genetic Test Disclosure for Coronary Artery Disease (PROACT 1 Trial)
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females between 40 and 75 years of age capable and willing to provide informed consent
Participant has high CAD PRS as defined on a clinical test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
PROACT 1 Trial Summary
This trial will study how a genetic test result affects people's heart health over a year.
Who is the study for?
This trial is for men and women aged 40-75 who have a high genetic risk for coronary artery disease but no history of cardiovascular diseases, severe liver or kidney conditions, or are on certain drugs. Pregnant or breastfeeding women and those with extreme obesity (BMI ≥ 40 kg/m2) are excluded.Check my eligibility
What is being tested?
The study tests the effect of informing participants about their high genetic risk for coronary artery disease to see if this knowledge leads to improved heart health over one year.See study design
What are the potential side effects?
Since the intervention involves only disclosing information about genetic risk, there are no direct physical side effects associated with typical medical treatments.
PROACT 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 75 years old and can give my consent.
Select...
My clinical test shows I have a high risk for coronary artery disease.
PROACT 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health
PROACT 1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants will receive their high polygenic risk result for coronary artery disease.
Group II: ControlActive Control1 Intervention
Participants will receive standard of care, and disclosure of high polygenic risk result will be deferred until study completion.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,924 Total Patients Enrolled
165 Trials studying Coronary Artery Disease
268,832 Patients Enrolled for Coronary Artery Disease
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,441 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
10,348 Patients Enrolled for Coronary Artery Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart or blood vessel disease.I am pregnant, breastfeeding, or might become pregnant during the study.My BMI is 40 or higher.My kidney function is reduced, with low filtration rates or high creatinine.You have visible plaque in your heart arteries on a specific type of scan.I am unable to understand and give consent for treatment.I am between 40 and 75 years old and can give my consent.I am not taking strong CY2P inhibitors like ketoconazole.I have liver disease or my recent liver tests are much higher than normal.I cannot hold my breath for 10 seconds.My clinical test shows I have a high risk for coronary artery disease.I am currently on medication to lower my LDL cholesterol or for inflammation.You have had a strong allergic reaction to iodinated contrast, colchicine, or statins in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the lower age limit for this experiment set at 85 years?
"The requirements for this medical study requires individuals to be between 40 and 75 years old. Meanwhile, there are 27 studies aimed at younger patients under 18 while 673 trials focus on older adults over 65."
Answered by AI
Is it possible for me to take part in this research endeavor?
"The qualifications for this medical trial include a diagnosis of coronary artery disease and being aged between 40 and 75. 600 participants in total are needed to complete the study."
Answered by AI
Does this clinical investigation still accept enrollees?
"As of April 6th 2023, this clinical trial is no longer accepting patients. It was initially posted on July 1st 2023 and has since been updated once more. However, there are 686 other trials actively enrolling participants at the moment."
Answered by AI
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