Coronary Heart DiseaseNCT05918380
Project 3: ACHIEVE- CHD
A study testing PAL2 and CINEMA in people with Coronary Heart Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- PAL2 and CINEMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 to 75 years of age
- Self-identified as Black or African American
- Residence in the Cleveland Metro Area
- 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:
- BMI≥30 mg/dL
- History of smoking
Show all 13Show fewer
- Elevated blood pressure defined as SBP>140 or DBP>80 mmHg
- HbA1c≥5.7%
- LDL≥130
- Able to complete a coronary artery calcium score test (CAC)
- Willing and able to consent
- Willing to have a UH provider and UH care
- Currently insured for standard of care procedures
Who cannot join
- Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke).
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
- Lung disease requiring supplemental oxygen therapy
- Individuals receiving treatment for cancer related disease
- Pregnant or nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region
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.
- Conditions
- Coronary Heart Disease
- Being tested
- PAL2, CINEMA
- Keywords
- Health Disparities, African American, Prevention, Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAL2Behavioural
Also called Pragmatic personalized, adaptable approach to lifestyle and life circumstance
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.
CINEMAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low CVD risk | Other | PAL2 Receives: Behavioral: PAL2 |
| High CVD risk | Other | Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) Receives: Other: CINEMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (4)
Change in HbA1c as measured by blood work
Percent change in HbA1c
Measured: baseline, 12 months
Change in LDL-C as measured by blood work
Percent change in LDL-C
Measured: baseline, 12 months
Change in blood pressure
Percent change in blood pressure
Measured: baseline, 12 months
Change in weight
Percent change in weight
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start15 Aug 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Rajagopalan, University Hospitals Cleveland Medical Center
- Investigators
- Sanjay Rajagopalan, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918380
- Sponsor's protocol ID
- STUDY20220763
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region
- ClinicalTrials.gov ID
- NCT05918380
- Acronym / sponsor ID
- STUDY20220763
- Conditions
- Coronary Heart Disease
- Keywords
- Health Disparities, African American, Prevention, Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low CVD risk | Other | Behavioral: PAL2PAL2 |
| High CVD risk | Other | Other: CINEMACenter for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 40 to 75 years of age
- Self-identified as Black or African American
- Residence in the Cleveland Metro Area
- 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:
- Able to complete a coronary artery calcium score test (CAC)
Key exclusion criteria (5 listed)
- Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke).
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
- Lung disease requiring supplemental oxygen therapy
- Individuals receiving treatment for cancer related disease
- Pregnant or nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAL2Also: Pragmatic personalized, adaptable approach to lifestyle and life circumstanceLow 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. | Behavioural | Low CVD risk |
| CINEMAHigh 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. | Other | High CVD risk |
Primary outcome
Triple Goal
Time frame: 12 months
Percent reaching triple goal of BP <130/80 mm Hg, HbA1c<5.7% and LDL-C <130 mg/dl (<100 if high-risk)
4 secondary outcomes
Change in HbA1c as measured by blood work
Time frame: baseline, 12 months
Change in LDL-C as measured by blood work
Time frame: baseline, 12 months
Change in blood pressure
Time frame: baseline, 12 months
Change in weight
Time frame: baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Heart Disease
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Rajagopalan, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAL2 and CINEMA in people with Coronary Heart Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triple Goal (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.