Coronary Artery DiseaseCAD-MAPNCT06202300
Myocardial and Arterial Phenotype of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital at 2 sites in China.
Trial summary
The CAD-MAP (Myocardial and Arterial Phenotype of Coronary Artery Disease) registry is initiated with the goal to describe the cardiac imaging map including epicardial coronary artery, coronary microcirculation and myocardium, and further exploring the prognostic value of multidimensional imaging biomarkers and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Inflammation burden
- How many people
- 5,000 participants
- Where
- 2 sitesChina
- Study dates
- 12 Mar 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected or confirmed CAD who are eligible to undergo coronary angiography and IVUS/OCT or functional tests.
Who may be able to join
- 1. Age ≥18 years old.
- 2. Patients with suspected or confirmed coronary artery disease who are eligible to undergo coronary angiography and IVUS/OCT or functional examination.
- 3. Written informed consent.
- 4. Subject is willing to comply with all protocol-required follow-up evaluation.
Who cannot join
- 1. Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.
- 2. Pregnancy, lactation, or potentially fertile women.
- 3. Patients who cannot complete this trial or comply with the protocol.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Xiao Wang, MD, 86-10-84005253, spaceeye123@126.com
Yingying Guo, MD, 86-10-84005253, ying15836089137@163.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Tieci Yi, PhD, 86-10-83575262, ytc_bjmu@126.com
About this study
Official title: Myocardial and Arterial Phenotype of Coronary Artery Disease (CAD-MAP): A Multicenter Multimodality Imaging & Physiology Registry
The CAD-MAP (Myocardial and Arterial Phenotype of Coronary Artery Disease) registry is initiated with the goal to describe the cardiac imaging map including epicardial coronary artery, coronary microcirculation and myocardium, and further exploring the prognostic value of multidimensional imaging biomarkers and predictive models in CAD patients.
Read the detailed description
Despite advances in medical therapy and the greater use of reperfusion therapy, morbidity and mortality following coronary artery disease (CAD) remains substantial, with increase in elder population and the epidemic of metabolic risk factors. The pathophysiological process of CAD involves the pathological changes of myocardium and coronary arteries. Current risk stratification based on traditional risk factors and clinical characteristics cannot reflect the comprehensive effects of risk factors on pathological features, thus providing limited prognostic value in CAD patients.
Invasive and noninvasive cardiovascular imaging techniques including vascular and myocardial imaging can lead to a better understanding of underlying pathological mechanisms of CAD and further improve phenotyping, thus allowing imaging-guided risk stratification and optimizing treatment effects. Coronary computed tomography angiography (CCTA), cardiac magnetic resonance (CMR), and positron emission tomography/computed tomography (PET/CT), which can directly capture coronary and myocardial features, offers a unique tool for the quantification of pathophysiological feature and for better risk stratification of CAD patients.
Current imaging cohorts, including UK Biobank, MESA and PESA, allow for evaluation of atherosclerosis cardiovascular disease. However, these cohorts aimed to evaluate the progression of subclinical atherosclerosis for primary prevention. Moreover, most imaging cohorts of secondary prevention included single imaging modality and few investigated the clinical effect of multimodality imaging-guided treatment in CAD patients.
Due to the absence of multimodality imaging study in CAD patients, the investigators perform a large-scale, retrospective/prospective observational cohort study:
- To identify the imaging and functional biomarkers related to CAD progression and clinical outcomes.
- To evaluate the diagnostic and prognostic value of novel imaging biomarkers (CCTA pericoronary fat attenuation index, 18F-NaF PET/CT microcalcification, CMR T2 mapping, etc) for coronary and myocardial inflammation, and the association between novel imaging biomarkers and cerebral metabolism and inflammation
- To evaluate the correlation and combination of different imaging/functional biomarkers (noninvasive or invasive) and develop the optimal imaging/functional biomarkers to predict recurrent CAD events.
- To explore the effect of lifestyle or behaviors (eating habit, physical exercise, and sleeping pattern), social psychological and environmental factors on the occurrence, progression, and recurrence of CAD
- To establish a novel risk stratification model including clinical factors, biomarkers and imaging markers, and explore the incremental predictive value of the novel model, in comparison to traditional clinical risk scores, for the prediction of clinical outcomes in CAD patients.
CCTA substudy: for patients with CCTA imaging, we aim to evaluate the diagnostic value and prognostic implication of one-stop CCTA test including degree of stenosis, lesions, CCTA-derived fractional flow reserve, shear force, and pericoronary adipose tissue, on culprit or high-risk lesions identified by optical coherence tomography (OCT).
PET-CT substudy: for patients with PET/CT examination, we aim to evaluate the association of neurometabolic activity by 18FDG PET/CT with plaque microcalcification by 18NaF PET/CT, pericoronary inflammation by CCTA, or high-risk plaque characteristics by OCT. Furthermore, the combined predictive value of these imaging markers will also be assessed.
CMR substudy: for STEMI patients with CMR, we aim to investigate the association of coronary angiography-derived index of microcirculatory resistance (angio-IMR) with myocardial injury and inflammation by CMR, and validate the prognostic value of combination of angio-IMR and CMR-derived parameters.
- Conditions
- Coronary Artery Disease
- Being tested
- Inflammation burden
- Keywords
- Coronary artery disease, Multimodality imaging, Inflammation, Clinical outcome
- Medical subject headings
- Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammation burdenOther
Coronary artery disease patients undergone multimodality imaging with different level inflammation burden
| Study group | Role | What they receive |
|---|---|---|
| Patients with high inflammation level | CAD patients undergoing multimodality imaging with high inflammation burden Receives: Other: Inflammation burden | |
| Patients with low inflammation level | CAD patients undergoing multimodality imaging with low inflammation burden Receives: Other: Inflammation burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACEs)
Including cardiovascular death, nonfatal myocardial infarction, ischemia-driven revascularization
Measured: Median 12 months
Secondary outcomes (11)
Major adverse cardiac and cerebrovascular events (MACCEs)
Including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization
Measured: Median 12 months
Cardiovascular death
Measured: Median 12 months
All-cause death
Measured: Median 12 months
Myocardial infarction
Measured: Median 12 months
Stroke
Measured: Median 12 months
Heart failure
Measured: Median 12 months
Target vessel revascularization
Measured: Median 12 months
Revascularization
Measured: Median 12 months
Hospitalization for unstable angina
Measured: Median 12 months
Stent thrombosis
Measured: Median 12 months
Bleeding events (BARC 2,3,5)
Measured: Median 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start12 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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 Beijing Anzhen HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Wang, Beijing Anzhen Hospital
- Investigators
- Xiao Wang, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202300
- Sponsor's protocol ID
- KS2023013
- Acronym
- CAD-MAP
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 11 Jan 2024
- 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial and Arterial Phenotype of Coronary Artery Disease (CAD-MAP): A Multicenter Multimodality Imaging & Physiology Registry
- ClinicalTrials.gov ID
- NCT06202300
- Acronym / sponsor ID
- CAD-MAP / KS2023013
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Multimodality imaging, Inflammation, Clinical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
The CAD-MAP (Myocardial and Arterial Phenotype of Coronary Artery Disease) registry is initiated with the goal to describe the cardiac imaging map including epicardial coronary artery, coronary microcirculation and myocardium, and further exploring the prognostic value of multidimensional imaging biomarkers and predictive models in CAD patients.
Detailed description
Despite advances in medical therapy and the greater use of reperfusion therapy, morbidity and mortality following coronary artery disease (CAD) remains substantial, with increase in elder population and the epidemic of metabolic risk factors. The pathophysiological process of CAD involves the pathological changes of myocardium and coronary arteries. Current risk stratification based on traditional risk factors and clinical characteristics cannot reflect the comprehensive effects of risk factors on pathological features, thus providing limited prognostic value in CAD patients.
Invasive and noninvasive cardiovascular imaging techniques including vascular and myocardial imaging can lead to a better understanding of underlying pathological mechanisms of CAD and further improve phenotyping, thus allowing imaging-guided risk stratification and optimizing treatment effects. Coronary computed tomography angiography (CCTA), cardiac magnetic resonance (CMR), and positron emission tomography/computed tomography (PET/CT), which can directly capture coronary and myocardial features, offers a unique tool for the quantification of pathophysiological feature and for better risk stratification of CAD patients.
Current imaging cohorts, including UK Biobank, MESA and PESA, allow for evaluation of atherosclerosis cardiovascular disease. However, these cohorts aimed to evaluate the progression of subclinical atherosclerosis for primary prevention. Moreover, most imaging cohorts of secondary prevention included single imaging modality and few investigated the clinical effect of multimodality imaging-guided treatment in CAD patients.
Due to the absence of multimodality imaging study in CAD patients, the investigators perform a large-scale, retrospective/prospective observational cohort study:
- To identify the imaging and functional biomarkers related to CAD progression and clinical outcomes.
- To evaluate the diagnostic and prognostic value of novel imaging biomarkers (CCTA pericoronary fat attenuation index, 18F-NaF PET/CT microcalcification, CMR T2 mapping, etc) for coronary and myocardial inflammation, and the association between novel imaging biomarkers and cerebral metabolism and inflammation
- To evaluate the correlation and combination of different imaging/functional biomarkers (noninvasive or invasive) and develop the optimal imaging/functional biomarkers to predict recurrent CAD events.
- To explore the effect of lifestyle or behaviors (eating habit, physical exercise, and sleeping pattern), social psychological and environmental factors on the occurrence, progression, and recurrence of CAD
- To establish a novel risk stratification model including clinical factors, biomarkers and imaging markers, and explore the incremental predictive value of the novel model, in comparison to traditional clinical risk scores, for the prediction of clinical outcomes in CAD patients.
CCTA substudy: for patients with CCTA imaging, we aim to evaluate the diagnostic value and prognostic implication of one-stop CCTA test including degree of stenosis, lesions, CCTA-derived fractional flow reserve, shear force, and pericoronary adipose tissue, on culprit or high-risk lesions identified by optical coherence tomography (OCT).
PET-CT substudy: for patients with PET/CT examination, we aim to evaluate the association of neurometabolic activity by 18FDG PET/CT with plaque microcalcification by 18NaF PET/CT, pericoronary inflammation by CCTA, or high-risk plaque characteristics by OCT. Furthermore, the combined predictive value of these imaging markers will also be assessed.
CMR substudy: for STEMI patients with CMR, we aim to investigate the association of coronary angiography-derived index of microcirculatory resistance (angio-IMR) with myocardial injury and inflammation by CMR, and validate the prognostic value of combination of angio-IMR and CMR-derived parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with high inflammation level | – | Other: Inflammation burdenCAD patients undergoing multimodality imaging with high inflammation burden |
| Patients with low inflammation level | – | Other: Inflammation burdenCAD patients undergoing multimodality imaging with low inflammation burden |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or confirmed CAD who are eligible to undergo coronary angiography and IVUS/OCT or functional tests.
Key inclusion criteria (4 listed)
- 1. Age ≥18 years old.
- 2. Patients with suspected or confirmed coronary artery disease who are eligible to undergo coronary angiography and IVUS/OCT or functional examination.
- 3. Written informed consent.
- 4. Subject is willing to comply with all protocol-required follow-up evaluation.
Key exclusion criteria (3 listed)
- 1. Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.
- 2. Pregnancy, lactation, or potentially fertile women.
- 3. Patients who cannot complete this trial or comply with the protocol.
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 |
|---|---|---|
| Inflammation burdenCoronary artery disease patients undergone multimodality imaging with different level inflammation burden | Other | Patients with high inflammation level, Patients with low inflammation level |
Primary outcome
Major adverse cardiac events (MACEs)
Time frame: Median 12 months
Including cardiovascular death, nonfatal myocardial infarction, ischemia-driven revascularization
11 secondary outcomes
Major adverse cardiac and cerebrovascular events (MACCEs)
Time frame: Median 12 months
Cardiovascular death
Time frame: Median 12 months
All-cause death
Time frame: Median 12 months
Myocardial infarction
Time frame: Median 12 months
Stroke
Time frame: Median 12 months
Heart failure
Time frame: Median 12 months
Target vessel revascularization
Time frame: Median 12 months
Revascularization
Time frame: Median 12 months
Hospitalization for unstable angina
Time frame: Median 12 months
Stent thrombosis
Time frame: Median 12 months
Bleeding events (BARC 2,3,5)
Time frame: Median 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- 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.
Xiao Wang, MD principal investigator
Beijing Anzhen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital at 2 sites in China.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Wang, MD (86-10-84005253, spaceeye123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACEs) (time frame: Median 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 11 Jan 2024.