CHART Study of Coronary CT Angiography in Coronary Artery Disease

NCT05380622 | Recruiting DMC

• 1 other identifier: CHART-20220510
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

In a cohort of patients referred to coronary computed tomography angiography (CCTA), the investigators aim:

1. 1.To describe the natural history of the coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA among deferred coronary lesions
2. 2.To explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) in deferred coronary lesions
3. 3.To investigate prognostic implication of qualitative and quantitative plaque analysis of stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment
4. 4.To investigate the effects of different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (13)

• Frequency of occurrence of high-risk plaques

  Frequency (%) of occurrence of high-risk plaque morphologic features (Housfield Unit\[HU\]\<30, Remodelling Index \> 1.1, napkin-ring sign, spotty calcium, minimal lumen area\[MLA\]\<4mm2 \& plaque burden\[PB\]≥70%), physiologic diffuse disease, inflammation by high fat attenuation index (FAI)

  30 days

• Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA

  Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA

  up to 5 years after index procedure

• Change in WSS detected by follow up CCTA

  Change in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA

  up to 5 years after index procedure

• Change in APS detected by follow up CCTA

  Change in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA

  up to 5 years after index procedure

• Change in SSI detected by follow up CCTA

  Change in stenosis susceptibility index (SSI) detected by follow up CCTA

  up to 5 years after index procedure

• Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA

  Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA

  up to 5 years after index procedure

• Change in physiological pattern by PPG derived by follow up CCTA

  Change in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA

  up to 5 years after index procedure

• Change in dCT-FFR/ds detected by follow up CCTA

  Change in dCT-FFR/ds detected by follow up CCTA

  up to 5 years after index procedure

• Change in CT-FFR

  Change in fractional flow reserve by CCTA

  up to 5 years after index procedure

• Change in peri-coronary adipose tissue assessed by follow up CCTA

  Change in peri-coronary adipose tissue assessed by follow up CCTA

  up to 5 years after index procedure

• CCTA-derived features associated with precursors of ACS or CCS

  CCTA-derived features associated with precursors of ACS or CCS

  up to 5 years after index procedure

• Adverse cardiovascular event according to stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment

  A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.

  up to 5 years after index procedure

• Adverse cardiovascular event according to different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.

  A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.

  up to 5 years after index procedure

Secondary Outcomes (14)

• Anginal status

  up to 5 years after index procedure

• Number of anti-anginal medication prescribed

  up to 5 years after index procedure

• Clinical predictors of events

  up to 5 years after index procedure

• Prognostic value of CCTA defined anatomy and plaque characterization

  up to 5 years after index procedure

• Prognostic value of WSS

  up to 5 years after index procedure

Study Arms (2)

Without ICA or deferral of PCI after ICA group

Patients didn't undergo invasive coronary angiography (ICA) or with a vessel determined to defer revascularization.

Diagnostic Test: Coronary CT angiography

PCI group

Patients with a vessel that undergo percutaneous coronary intervention (PCI)

Diagnostic Test: Coronary CT angiography

Interventions

Coronary CT angiography DIAGNOSTIC_TEST

Coronary CT angiography (CCTA) will be performed according to standard protocol and measurement of fractional flow reserve (FFR) or other physiological indices will be at the at the discretion of the physicians in charge. Stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA will be analyzed blindly in the core lab.

PCI group; Without ICA or deferral of PCI after ICA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for CCTA.

You may qualify if:

• Patients with an indication for CCTA.
• Qualified patients who have signed a written informed consent form.

You may not qualify if:

• Left ventricular ejection fraction \< 35%
• Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
• Abnormal epicardial coronary flow (TIMI flow \< 3)
• Planned coronary artery bypass graft surgery after diagnostic angiography
• Poor quality of CCTA or other reasons by core lab that are unsuitable for plaque, physiological or fat analysis
• Patients with a stent in the target vessel

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Neng Dai, MD

CONTACT

+8613701997266; niceday1987@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 19, 2022
• Study Start: January 1, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

CN (1)