Project 3: ACHIEVE- CHD

Coronary Heart Disease Clinical Trial

Official title:

ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918380
• Other study ID #: STUDY20220763
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Sanjay Rajagopalan, MD
• Phone: 216-844-5191
• Email: Sanjay.Rajagopalan[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• PAL2
Low CVD risk participants (CAC < 100) will be followed by their primary care provider accompanied by monthly contact with community health workers provided by ACHIEVE Greater who will screen participants for social determinants of health and implement the PAL2. PAL2 is defined as a community health worked based intervention to mitigate psychosocial and health equity barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education.

Other:
• CINEMA
High CVD risk participants (CAC = 100) will be followed by specialists in the Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) at UHCMC. While they too will be assessed, by the CHW for SDOH and a plan developed to address them, this plan will be addressed by the usual resources available in the CINEMA clinic.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Visits and Lifestyle Changes - Medical/Mental Health Visits	1-year rate of new medical/mental health visits	12 months after cessation of intervention or 24 months after enrollment
Other	Health Visits and Lifestyle Changes - Smoking Cessation	1-year rate of smoking cessation	12 months after cessation of intervention or 24 months after enrollment
Other	Health Visits and Lifestyle Changes - Diet	1-year rate of changes in diet	12 months after cessation of intervention or 24 months after enrollment
Other	Health Visits and Lifestyle Changes - Activity	1-year rate of changes in activity	12 months after cessation of intervention or 24 months after enrollment
Primary	Triple Goal	Percent reaching triple goal of BP <130/80 mm Hg, HbA1c<5.7% and LDL-C <130 mg/dl (<100 if high-risk)	12 months
Secondary	Change in HbA1c as measured by blood work	Percent change in HbA1c	baseline, 12 months
Secondary	Change in LDL-C as measured by blood work	Percent change in LDL-C	baseline, 12 months
Secondary	Change in blood pressure	Percent change in blood pressure	baseline, 12 months
Secondary	Change in weight	Percent change in weight	baseline, 12 months