Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202300
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2024-01-01
Brief Title:
Myocardial and Arterial Phenotype of Coronary Artery Disease
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
Myocardial and Arterial Phenotype of Coronary Artery Disease CAD-MAP A Multicenter Multimodality Imaging Physiology Registry
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAD-MAP
Brief 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 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 tomographycomputed tomography PETCT 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 retrospectiveprospective 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 PETCT 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 imagingfunctional biomarkers noninvasive or invasive and develop the optimal imagingfunctional 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 PETCT examination we aim to evaluate the association of neurometabolic activity by 18FDG PETCT with plaque microcalcification by 18NaF PETCT 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
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 tomographycomputed tomography PETCT 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 retrospectiveprospective 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 PETCT 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 imagingfunctional biomarkers noninvasive or invasive and develop the optimal imagingfunctional 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 PETCT examination we aim to evaluate the association of neurometabolic activity by 18FDG PETCT with plaque microcalcification by 18NaF PETCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None