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The Precision CAD Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04755413
Recruitment Status : Not yet recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University

Study Description
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Brief Summary:
People with Coronary Artery Disease (CAD) have narrow or blocked arteries that supply blood to the heart. Reduced blood flow to the heart muscle from CAD can cause chest pain or aching, especially with exercise or activity. CAD can lead to weakening of the heart muscle or heart failure, and a higher risk of heart attack or death. Certain proteins in the blood, known as biomarkers, can be found in people with CAD. Higher levels of these biomarkers are associated with a greater risk of complications from CAD. The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Medical/Behavioral therapy Other: Standard of Care Other: Registry Not Applicable

Detailed Description:

People with Coronary Artery Disease (CAD) have narrow or blocked arteries that supply blood to the heart. Reduced blood flow to the heart muscle from CAD can cause chest pain or aching, especially with exercise or activity. CAD can lead to weakening of the heart muscle or heart failure, and a higher risk of heart attack or death. Certain proteins in the blood, known as biomarkers, can be found in people with CAD. Higher levels of these biomarkers are associated with a greater risk of complications from CAD. The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.

Participants with high biomarker levels will be randomly assigned (like flipping a coin) to either the treatment group or usual care. Both groups will have physical exams, blood tests, and answer questionnaires. Participants in the treatment group will have their medications adjusted based on their biomarker levels. They will also be asked to make lifestyle changes like diet, exercise, and quitting smoking. Participants in the usual care group will receive the standard of care prescribed by their doctor.

This study will take place in research rooms at Emory University Hospital and the Woodruff Memorial Research Building.

Participants will be paid for being in the study.

Participants will be recruited from Emory Healthcare outpatient cardiology clinics and cath labs. Participants will be identified through the medical record and by their doctors. Written consent will be obtained from Participants before they can join the study.

Study data and blood samples will be collected and banked for possible research in the future. These may also be shared with other researchers including researchers outside of Emory.

This study will advance scientific knowledge and benefit human health by giving us more treatment options for CAD.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease: The Precision CAD Trial
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Optimization Group
Participants with CAD and a BRS greater than 0 who are randomized to the Optimization Group have treatment goals that include achieving LDL-C<70 mg/dL, hemoglobin A1c <7%, blood pressure <130/80 mmHg, smoking cessation, at least 30 minutes of moderate-intensity aerobic activity 5 days a week and weight loss to body mass index <30 kg/m2. To achieve these goals, both pharmacological and lifestyle interventions will be considered and individualized for each patient.
 Other: Medical/Behavioral therapy
  • Sedentary lifestyle: Advise increasing exercise to at least 30 minutes of moderate-intensity aerobic activity 5 days a week.
  • Overweight/Obese: Advise calorie reduction, dietician consultation.
  • Smoking: standard smoking cessation advice and literature and medical therapy as indicated to include Wellbutrin, nicotine patch etc.

  • High LDL cholesterol: a) Start high dose statin if patient not on high dose statin.

    b) If on high dose statin, add ezetimibe 10mg daily c) If statin intolerant, start ezetimibe 10mg, colestid or other bile sequestrant combination.

    d) If still not at goal, start PCSK-9 inhibitor e) LDL cut off of <55mg/dl in diabetes

  • Blood Pressure optimization treatment following 2020 International Society of Hypertension Global Hypertension Practice Guidelines.
  • Diabetes management: HbA1c goal 6.5%
Active Comparator: Usual Care Group
Participants with CAD and a BRS greater than 0 who are randomized to the usual care group will receive standard of care therapy prescribed by their primary care physician and/or cardiologist. Patients and their physicians will be informed that their BRS is ≥1 and they have been randomized to the usual care group.
 Other: Standard of Care
Participants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist.
Registry Group
Participants with BRS of 0 at baseline and after 3 months will undergo follow-up including measurements of BRS at the time-points specified for the randomized subjects and also for adverse events. Laboratory results and questionnaire data will be obtained on the phone.
 Other: Registry
Participants with BRS of 0 will get measurements of BRS at the time-points specified for the randomized subjects and also for adverse events.


Outcome Measures
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Primary Outcome Measures :
  1. Change in plasma levels of hsCRP [ Time Frame: Baseline, 1 year post intervention ]
    Blood will be drawn for measurement of plasma levels of hsCRP to compare the optimization group and the usual care group.

  2. Change in plasma levels of hs-cTnI [ Time Frame: Baseline, 1 year post intervention ]
    Blood will be drawn for measurement of plasma levels of hs-cTnI to compare the optimization group and the usual care group.

  3. Change in plasma levels of BNP [ Time Frame: Baseline, 1 year post intervention ]
    Blood will be drawn for measurement of plasma levels of BNP to compare the optimization group and the usual care group.

  4. Change in plasma levels of suPAR [ Time Frame: Baseline, 1 year post intervention ]
    Blood will be drawn for measurement of plasma levels of suPAR to compare the optimization group and the usual care group.

  5. Change in Biomarker Risk Score (BRS) [ Time Frame: Baseline, 1 year post intervention ]
    The BRS score is a simple and manual observation of 4 biomarker results above a predetermined cutpoint that are run on FDA cleared and or CE marked platforms. The BRS is calculated using levels of the 4 biomarkers. Biomarker levels will be considered abnormal if hsCRP is >3 mg/L, suPAR (pg/mL) >2863 (males) and >4063 (women), hs-TnI (pg/mL)> 6.3 (men), >5.5 (women), and BNP (pg/mL) >122 (men), >184.1 (women). The BRS ranges from 0 to 4 based on the number of biomarkers that are elevated above these cut off values. Higher score correlates with worse outcome.

  6. Change in composite complications [ Time Frame: Baseline, 1,3,6,9 months post intervention and 1,2,3,5 years post intervention ]
    Difference in rates of composite of CV death/MI/ heart failure hospitalizations, stroke/ revascularization between optimization group, usual care group and registry group.


Secondary Outcome Measures :
  1. Change in plasma levels of hsCRP [ Time Frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention ]
    Blood will be drawn for measurement of plasma levels of hsCRP to compare the optimization group and the usual care group.

  2. Change in plasma levels of hs-cTnI [ Time Frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention ]
    Blood will be drawn for measurement of plasma levels of hs-cTnI to compare the optimization group and the usual care group.

  3. Change in plasma levels of BNP [ Time Frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention ]
    Blood will be drawn for measurement of plasma levels of BNP to compare the optimization group and the usual care group.

  4. Change in plasma levels of suPAR [ Time Frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention ]
    Blood will be drawn for measurement of plasma levels of suPAR to compare the optimization group and the usual care group.

  5. All cause death [ Time Frame: 5 years post intervention ]
    All cause death at 5 years in the optimization group compared to usual care group.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • individuals aged 21-90 years with stable CAD.
  • Patients with plaque at angiography exceeding >50% in one or more coronary arteries at any time will be eligible. Current obstructive CAD is not required for eligibility.
  • Patients undergoing revascularization therapy or recent acute coronary syndrome (ACS) will be eligible for recruitment and will be recruited at least 4 weeks after admission for an ACS or percutaneous intervention and 3 months after coronary bypass graft surgery.

Exclusion Criteria:

  • planned revascularization,
  • New York Heart Association class III or IV heart failure symptoms,
  • LVEF <40%,
  • eGFR<45,
  • pregnancy, congenital heart disease, severe symptomatic valvular heart disease, active malignancy and cardiac transplant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755413


Contacts
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Contact: Joey Freshwater 404-712-6635 joey.freshwater@emory.edu

Locations
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United States, Georgia
Emory Johns Creek Hospiatl
Atlanta, Georgia, United States, 30097
Contact: Joey Freshwater         
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Contact: Joey Freshwater         
Emory University Hospital
Atlanta, Georgia, United States, 30322
Contact: Joey Freshwater         
The Emory Clinic
Atlanta, Georgia, United States, 30324
Contact: Joey Freshwater         
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Contact: Joey Freshwater         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Arshed Quyyumi, MD Emory University
More Information
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Responsible Party: Arshed A. Quyyumi, Professor, Emory University
ClinicalTrials.gov Identifier: NCT04755413    
Other Study ID Numbers: STUDY00001179
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arshed A. Quyyumi, Emory University:
Coronary Artery Disease
Biomarkers
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases