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

NCT ID: NCT06843005

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2028-12-30

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.

Detailed Description

Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients.

The SUCCESS study is a single-center, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CCTA-based follow-up management group

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

Group Type: ACTIVE_COMPARATOR

Coronary Computed Tomography Angiography

Intervention Type: DIAGNOSTIC_TEST

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

clinical-based follow-up management group

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.

Group Type: SHAM_COMPARATOR

Current clinical guidelines

Intervention Type: OTHER

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

Interventions

Coronary Computed Tomography Angiography

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

Intervention Type: DIAGNOSTIC_TEST

Current clinical guidelines

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 80 years old;

2. Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);

3. Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.

Exclusion Criteria

1. Patients who have experienced ACS or PCI/CABG;

2. Patients who have experienced adverse cardiovascular and cerebrovascular events;

3. Patients who have undergone follow-up CCTA or DSA examinations before enrollment;

4. Patients with severe hepatic and renal dysfunction;

5. Patients with contraindications to CCTA examinations;

6. Patients with poor initial CCTA image quality or data loss.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhang longjiang,MD

OTHER

Sponsor Role: lead

Responsible Party

Zhang longjiang,MD

Principal Investigator : Zhang longjiang

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Trail Manager

Role: STUDY_CHAIR

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

Locations

Research Institute Of Medical Imaging Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Longjiang Zhang, MD

Role: CONTACT

kevinzhlj@163.com

13405833167

Facility Contacts

Longjiang Zhang, MD

Role: primary

kevinzhlj@163.com

13405833176

Chao Li, MD

Role: backup

lclive123123@163.com

18822060230

Other Identifiers

2024DZKY-132-01

Identifier Type: -

Identifier Source: org_study_id