Coronary Artery DiseaseNCT04755413
The Precision CAD Trial
A study testing Medical/Behavioral therapy and Registry in people with Coronary Artery Disease, run by Emory University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Medical/Behavioral therapy and Registry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Oct 2022to Dec 2028
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 21-90 years with stable CAD.
- Patients with any amount of atherosclerosis via coronary angiogram or coronary computed tomography angiography (CCTA).
- 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.
- Patients with CAC levels ≥ 400
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory Johns Creek Hospiatl
Atlanta, Georgia, 30097
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30324
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease: The Precision CAD Trial
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Medical/Behavioral therapy, Standard of Care, Registry
- Keywords
- Coronary Artery Disease, Biomarkers
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical/Behavioral therapyOther
- 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.
- If on high dose statin, add ezetimibe 10mg daily c) If statin intolerant, start ezetimibe 10mg, colestid or other bile sequestrant combination.
- 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%
Standard of CareOther
Participants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist.
RegistryOther
Participants with BRS of 0 will get measurements of BRS at the time-points specified for the randomized subjects and also for adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Optimization Group | Experimental | 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. Receives: Other: Medical/Behavioral therapy |
| Usual Care Group | Active comparator | 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. Receives: Other: Standard of Care |
| Registry Group | Other | 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. Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma levels of hsCRP
Blood will be drawn for measurement of plasma levels of hsCRP to compare the optimization group and the usual care group.
Measured: Baseline, 1 year post intervention
Change in plasma levels of hs-cTnI
Blood will be drawn for measurement of plasma levels of hs-cTnI to compare the optimization group and the usual care group.
Measured: Baseline, 1 year post intervention
Change in plasma levels of BNP
Blood will be drawn for measurement of plasma levels of BNP to compare the optimization group and the usual care group.
Measured: Baseline, 1 year post intervention
Change in plasma levels of suPAR
Blood will be drawn for measurement of plasma levels of suPAR to compare the optimization group and the usual care group.
Measured: Baseline, 1 year post intervention
Change in Biomarker Risk Score (BRS)
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.
Measured: Baseline, 1 year post intervention
Change in composite complications
Difference in rates of composite of CV death/MI/ heart failure hospitalizations, stroke/ revascularization between optimization group, usual care group and registry group.
Measured: Baseline, 1,3,6,9 months post intervention and 1,2,3,5 years post intervention
Secondary outcomes (5)
Change in plasma levels of hsCRP
Blood will be drawn for measurement of plasma levels of hsCRP to compare the optimization group and the usual care group.
Measured: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Change in plasma levels of hs-cTnI
Blood will be drawn for measurement of plasma levels of hs-cTnI to compare the optimization group and the usual care group.
Measured: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Change in plasma levels of BNP
Blood will be drawn for measurement of plasma levels of BNP to compare the optimization group and the usual care group.
Measured: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Change in plasma levels of suPAR
Blood will be drawn for measurement of plasma levels of suPAR to compare the optimization group and the usual care group.
Measured: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
All cause death
All cause death at 5 years in the optimization group compared to usual care group.
Measured: 5 years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start19 Oct 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed A. Quyyumi, Emory University
- Investigators
- Arshed Quyyumi, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755413
- Sponsor's protocol ID
- STUDY00001179
- Status last verified
- Nov 2025
- First submitted
- 11 Feb 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease: The Precision CAD Trial
- ClinicalTrials.gov ID
- NCT04755413
- Acronym / sponsor ID
- STUDY00001179
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Feb 2021 (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.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optimization Group | Experimental | Other: Medical/Behavioral therapyParticipants 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. |
| Usual Care Group | Active comparator | Other: Standard of CareParticipants 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. |
| Registry Group | Other | Other: RegistryParticipants 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 21-90 years with stable CAD.
- Patients with any amount of atherosclerosis via coronary angiogram or coronary computed tomography angiography (CCTA).
- 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.
- Patients with CAC levels ≥ 400
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| 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% | Other | Optimization Group |
| Standard of CareParticipants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist. | Other | Usual Care Group |
| RegistryParticipants with BRS of 0 will get measurements of BRS at the time-points specified for the randomized subjects and also for adverse events. | Other | Registry Group |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Change in plasma levels of hsCRP
Time frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Change in plasma levels of hs-cTnI
Time frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Change in plasma levels of BNP
Time frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Change in plasma levels of suPAR
Time frame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
All cause death
Time frame: 5 years post intervention
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 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Arshed Quyyumi, MD principal investigator
Emory University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical/Behavioral therapy and Registry in people with Coronary Artery Disease, run by Emory University at 5 sites 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 4 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Change in plasma levels of hsCRP (time frame: Baseline, 1 year post intervention). The study lists 6 primary outcomes in all. 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 21 Nov 2025.