The African American Heart Study is an observational study (that means, there are no investigational drugs or devices involved), requiring one single visit to your doctor’s office.
The study aims to provide insights into how lipoprotein(a) and cardiovascular disease are related in African Americans, a group that has historically been underrepresented in clinical research and are disproportionately affected by cardiovascular disease compared with other racial and ethnic groups.
This study is seeking volunteers that self-report as Black, African American, or of African descent, and are between 18 – 85 years old. You do not need to have a history of heart disease to be selected for the study.
By joining the African American Heart Study (the “Study”) you will be part of a community of individuals who are taking control of their heart health, and you will learn about your genetic risk for heart disease by knowing your Lp(a) levels.
The Study has minimal risks because there is no investigational drug being studied.
The Study is sponsored by Amgen and led by Global Principal Investigator Dr. Elizabeth Ofili, a practicing cardiologist, past Board Chair of the Association of Black Cardiologists and founder of Accuhealth Technologies, Inc. (“Accuhealth”) and Health 360x, a remote patient monitoring platform that has helped thousands of patients manage chronic illness including diabetes. Dr. Ofili is globally recognized for her expertise in cardiovascular health disparities in women and the African American community and has been continuously funded by the National Institute of Health (NIH) since 1994, with a track record of growing the clinical research infrastructure and training programs at Morehouse School of Medicine with awards totaling over $175 million.
Health 360x is a chronic disease and population health management platform operating under Accuhealth. For purposes of the African American Heart Study, participants leverage the Health 360x platform to complete a health survey and schedule visits with a health coach to discuss the results of the lab tests and results of the Study. Visit our website here, to learn more about how you can benefit from the Health 360x platform to monitor your blood pressure, blood sugar, body mass index, and cholesterol.
Lipoproteins are particles made of protein and fats (lipids). They carry cholesterol through your bloodstream to your cells. The two main groups of lipoproteins are called HDL (high-density lipoprotein) and LDL (low-density lipoprotein).
Lp(a) is made up of an LDL particle with a protein called apolipoprotein(a) or apo(a) attached to it. Lp(a) is stickier than other types of cholesterol, which may be why high levels are more likely to block arteries and increase risk for heart disease, stroke and other serious heart-related conditions.
There are regional Principal Investigators (“PI’s”) involved in directly recruiting patients into the Study, who are physicians practicing in cities – both urban and rural, all over the United States. Should you participate in the Study, you will be visiting the clinic of one of our regional PIs. Over 90% of the PIs in the Study are African American physicians and this is by design, to ensure the Study is inclusive and reaches more diverse patients.
Preparations for an Lp(a) test depend on the lab doing the test. Usually, you need to fast (not eat or drink) for 9 to 12 hours before your blood is drawn. Your provider will let you know if there are any special instructions to follow.
There is very little risk to having a blood test. You may have slight pain or bruising at the spot where the needle was put in, but most symptoms go away quickly.
A high Lp(a) level may mean you have a high risk for heart and blood vessel disease, even if your cholesterol levels are normal and you are healthy. Each participant in the Study will be assigned to and schedule a visit with a Health coach to discuss the lab result and learn how to manage your lifestyle (diet, exercise, and potentially medication) to optimize for a healthy outcome.
High Lp(a) occurs in all races or ethnicities, but it seems more common in Black individuals than in White, Hispanic, or East Asian individuals. In fact, the amount of Lp(a) your body produces is determined by genes you received at birth from your parents.
Clinical researchers determine if new interventions, including potential treatments, healthcare technology, healthcare services, and medical devices, are safe and effective for humans. People may react differently to the same treatment, based on their age, sex, weight, race, ethnicity, and other factors. Clinical research relies on volunteers to take part, and it’s vital that these people come from diverse backgrounds. By including people from diverse backgrounds, clinical research can show if the treatments are safe and work well for people from all different communities.
Interventional studies are clinical trials in which people participate to determine whether investigational drugs or treatments are safe and effective for humans. All investigational medications and devices must undergo clinical trials before making them available.
There are also observational studies, like the African American Heart Study, in which researchers ask people to be observed without intervention and no investigational drugs are being studied.
Participant information will be kept secret within the limits of local and national laws in the United States. If the results of this clinical research are published or presented in a meeting, the results will be encoded and individual participants will not be named.
Participants can decide to leave the Study at any time, for any reason. There is no charge or penalty for choosing not to take part in the Study.