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Groundbreaking study probes genes and environment to explain heart disease in black communities

NCT ID NCT02055209

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 15 times

Summary

This completed study looked at 670 African American adults to understand how genetics, lifestyle, and social factors like stress and neighborhood affect heart disease risk. Researchers collected blood samples, medical tests, and surveys to find links between ancestry-related DNA variations and conditions like high blood pressure. The goal is to explain why heart disease is more common in this group and to guide future prevention efforts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could reveal why African Americans have higher rates of heart disease and point to new ways to prevent it.
What could go wrong
This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results may take years to apply.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

670 people

The number who actually took part.

Started

Jul 2014

Finished

Mar 2024

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Primary Clinical and community sample

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Community-based self-identified (non-institutionalized), US-born, African American men and women age 21-65 will be included in the study. This criterion is inclusive of self-identified AA of both Hispanic and non-Hispanic ethnicity. EXCLUSION CRITERIA: Pregnant women are excluded from all aspects of the protocol. Adults who are unable to provide informed consent will be excluded. There are various reasons for excluding pregnant women from all protocol activities. It is well established that many of the primary and secondary study outcome variables and covariates being assessed by the protocol are significantly influenced by the pregnant state. For example pregnancy is known to affect multiple key study variables such as: blood pressure, endothelial function, vascular compliance/stiffness, body mass index, glucose-insulin metabolism and various neurohumoral factors involved in cardiovascular homeostasis. Similarly, pregnancy may have a confounding effect on important behavioral and psycho-social parameters under study (e.g. diet, sleep habits, physical activity, perceived stress, depression). Moreover, it is anticipated that a long-term objective of the study is to "call-back" many GENE-FORECAST participants for either follow-up and/or serial, longitudinal assessments of certain key parameters. It is therefore essential that the initial baseline evaluation not involve a transient condition such as pregnancy that has such profound effects on the cardio-metabolic phenotype under study. Neonates are excluded because they are less than the age of 21 years. Non-English speaking African Americans and those not born in the United States will be excluded. These individuals will be excluded because the exposure to social determinants experienced by African Americans born in the US differs from that of Africans born elsewhere and because the survey instruments in this protocol have only been verified in English speaking African-Americans. Furthermore, African immigrants are likely to have metabolic and cardiovascular profiles that are distinct from African Americans, and this could be a source of uncharacterized confounding factors. Those with severe and disabling co-morbidities associated with end-stage CVD will be excluded such as a recent history of hospitalization for manifestations of cardiovascular disease. More specifically, patients with a history of stroke, heart attack and/or heart failure in the past 12 months will be excluded. Nursing females will be excluded from FGD PET/CT and/or PET/MRI. Participants with pacemakers and/or any history of metal device implantation and/or metal in their body will be excluded from MRI according to clinical center guidelines. Participants with implanted electronic medical device will be excluded from percent body fat measurement. For CTA, patients with known allergic reaction to contrast will not be given contrast. Diabetic patients taking metformin will be excluded from receiving CTA IV contrast agents. Patients with renal failure (eGFR\<60) will not be given either MRI or CTA IV contrast. Adults who are or may be unable to consent are excluded due to their lack of knowledge to study components.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Southern Research Group

    Jackson, Mississippi, United States

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Other studies related to the condition(s) this trial covers.