The Bridging Antiplatelet Therapy With Cangrelor 2 Study
NCT07225842
Arterial Occlusive Diseases, Arteriosclerosis
Jacksonville, Florida, United States
View Trial DetailsNCT Number: NCT06794684
This is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Comprehensive morphological and functional plaque analysis will be performed. The impact of these morphological and functional parameters, alongside cardiometabolic factors and pharmacological treatments on plaque progression and the occurrence of major adverse cardiovascular events (MACEs) will be analyzed. In addition, intracoronary imaging techniques will be used to improve the accuracy of plaque analysis by coronary CTA.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital, Shanghai, China
This is a combined cohort study with retrospectively and prospectively enrolled patients. Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. For patients referred to invasive coronary angiography, intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS) will be performed. For all the prospectively enrolled patients, plasma and serum blood samples will be collected.
The purpose of this study is to investigate the natural history of coronary atherosclerotic plaques in this population. Comprehensive morphological plaque analysis will be performed to evaluate total atheroma volume (TAV), percent atheroma volume (PAV), plaque composition, high risk plaque features, and characteristics of perivascular adipose tissue (PVAT). Functional analysis will also be conducted to calculate hemodynamic parameters such as wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RTT), transverse WSS (transWSS), axis plaque stress (APS), fractional flow reserve (FFR), and δFFR across lesions. The associations of these morphological and functional parameters with plaque progression and the onset of major adverse cardiovascular events (MACEs) will be analyzed. In addition, the impact of pharmacological treatments and the levels of cardiometabolic factors on coronary plaque progression will also be investigated.
In the subpopulation who also receive intracoronary imaging examinations, intracoronary imaging modalities will be used to refine the inner and outer vessel contours, improve the accuracy of plaque composition characterization, and aid in the discovery of novel high-risk plaque features by coronary CTA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months
changes in TAV in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 5 years
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up
Time frame: 5 years
The occurrence of cardiovascular death during follow-up
Time frame: 5 years
The occurrence of myocardial infarction during follow-up
Time frame: 5 years
The occurrence of unplanned revascularization during follow-up
Time frame: 24 months
Changes in calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in non-calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in fibrous plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in fibrousfatty plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in plaque necrotic core volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in the number of HRP features in whole heart and in target lesions measured by coronary CTA at baseline and during follow-up.
Time frame: 24 months
Changes in the volume of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in the density of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Time frame: 24 months
Changes in the distribution of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Contact information is provided by the study sponsor or research team.
Shuo Feng
CONTACT
Xiaoqun Wang
CONTACT
Ruijin Hospital
Other
Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
Acronym: PRACTICE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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