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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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

    Recruiting

Other trials in China

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:

  1. To identify the imaging and functional biomarkers related to CAD progression and clinical outcomes.
  2. 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
  3. 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.
  4. 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
  5. 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.

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 groups in NCT06202300
Study groupRoleWhat they receive
Patients with high inflammation levelCAD patients undergoing multimodality imaging with high inflammation burden
Receives: Other: Inflammation burden
Patients with low inflammation levelCAD 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.

  1. Major adverse cardiac events (MACEs)

    Including cardiovascular death, nonfatal myocardial infarction, ischemia-driven revascularization

    Measured: Median 12 months

Secondary outcomes (11)
  1. Major adverse cardiac and cerebrovascular events (MACCEs)

    Including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization

    Measured: Median 12 months

  2. Cardiovascular death

    Measured: Median 12 months

  3. All-cause death

    Measured: Median 12 months

  4. Myocardial infarction

    Measured: Median 12 months

  5. Stroke

    Measured: Median 12 months

  6. Heart failure

    Measured: Median 12 months

  7. Target vessel revascularization

    Measured: Median 12 months

  8. Revascularization

    Measured: Median 12 months

  9. Hospitalization for unstable angina

    Measured: Median 12 months

  10. Stent thrombosis

    Measured: Median 12 months

  11. 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.

  1. First posted11 Jan 2024
  2. Study start12 Mar 2023
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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)
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

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.

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