| NCT ID | NCT05918380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-08-15 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 3 of the ACHIEVE GREATER Center.
Eligibility Criteria
Inclusion Criteria: 1. 40 to 75 years of age 2. Self-identified as Black or African American 3. Residence in the Cleveland Metro Area 4. Must have at least two of the following risk factors identified at a UH health fair screenings, with one risk factor being with SBP, A1c, or LDL: 1. BMI≥30 mg/dL 2. History of smoking 3. Elevated blood pressure defined as SBP\>140 or DBP\>80 mmHg 4. HbA1c≥5.7% 5. LDL≥130 5. Able to complete a coronary artery calcium score test (CAC) 6. Willing and able to consent 7. Willing to have a UH provider and UH care 8. Currently insured for standard of care procedures Exclusion Criteria: 1. Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke). 2. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg 3. Lung disease requiring supplemental oxygen therapy 4. Individuals receiving treatment for cancer related disease 5. Pregnant or nursing mothers
Contact & Investigator
Sanjay Rajagopalan, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT05918380 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05918380 currently recruiting?
Yes, NCT05918380 is actively recruiting participants. Contact the research team at Sanjay.Rajagopalan@uhhospitals.org for enrollment information.
Where is the NCT05918380 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05918380 clinical trial?
NCT05918380 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Sanjay Rajagopalan, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 500 participants.