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

Zhang longjiang,MD

Status: Enrolling

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

Treatments: Diagnostic Test: Coronary Computed Tomography Angiography; Other: Current clinical guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT06843005

2024DZKY-132-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,100 participants in 2 patient groups

CCTA-based follow-up management group

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Coronary Computed Tomography Angiography

clinical-based follow-up management group

Sham Comparator group

Description:

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.

Treatment:

Other: Current clinical guidelines