Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease

NCT06843005 | Recruiting DMC

• 1 other identifier: 2024DZKY-132-01
• Study Type: interventional
• Target: 3,100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.

Conditions

CT Angiography; Prevention; Coronary Artery Disease(CAD); Major Adverse Cardiovascular Events (MACE)

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebrovascular event

  Record the number of participants experiencing major adverse cardiovascular and cerebrovascular event such as all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke

  36 months after baseline

Secondary Outcomes (14)

• LDL-C control rate

  12 months after baseline

• Mean LDL-C changes

  12 months after baseline

• Adherence to lipid-lowering medication rate

  12 months after baseline

• The difference in healthcare-seeking rates between the two groups

  12 months after baseline

• Hypertension control rate

  12 months after baseline

Study Arms (2)

CCTA-based follow-up management group

ACTIVE COMPARATOR

The subjects will undergo routine clinical and laboratory examinations, as well as follow-up CCTA examinations to assess the progression of plaques and to recommend appropriate management, treatment, and follow-up based on the findings

Diagnostic Test: Coronary Computed Tomography Angiography

clinical-based follow-up management group

SHAM COMPARATOR

The subjects will undergo routine clinical and laboratory examinations, and recommendations for appropriate management, treatment, and follow-up will be made based on the results.

Other: Current clinical guidelines

Interventions

Coronary Computed Tomography Angiography DIAGNOSTIC_TEST

Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment.

CCTA-based follow-up management group

Current clinical guidelines OTHER

Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.

clinical-based follow-up management group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years old;
• Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
• Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.

You may not qualify if:

• Patients who have experienced ACS or PCI/CABG;
• Patients who have experienced adverse cardiovascular and cerebrovascular events;
• Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
• Patients with severe hepatic and renal dysfunction;
• Patients with contraindications to CCTA examinations;
• Patients with poor initial CCTA image quality or data loss.

Sponsors & Collaborators

• Zhang longjiang,MD: lead

Study Sites (1)

Research Institute Of Medical Imaging Jinling Hospital

Nanjing, Jiangsu, 210018, 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

• Trail Manager

  Jinling Hospital,Nanjing University School of Medicine,Nanjing,China

  STUDY CHAIR

Central Study Contacts

Longjiang Zhang, MD

CONTACT

13405833167; kevinzhlj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator : Zhang longjiang

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 24, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CN (1)