Clinical trial NCT06843005: Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease
Official title: Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Adverse Cardiovascular Events (MACE)
Prevention
Coronary Artery Disease(CAD)
CT Angiography
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Major adverse cardiovascular and cerebrovascular event
timeFrame: 36 months after baseline
Secondary outcomes:
measure: LDL-C control rate
timeFrame: 12 months after baseline
measure: Mean LDL-C changes
timeFrame: 12 months after baseline
measure: Adherence to lipid-lowering medication rate
timeFrame: 12 months after baseline
measure: The difference in healthcare-seeking rates between the two groups
timeFrame: 12 months after baseline
measure: Hypertension control rate
timeFrame: 12 months after baseline
measure: Diabetic control rate
timeFrame: 12 months after baseline
measure: Cardiac death
timeFrame: 36 months after baseline
measure: Fatal and non-fatal myocardial infarction or stroke
timeFrame: 36 months after baseline
measure: Rehospitalization due to progressive angina
timeFrame: 36 months after baseline
measure: Major adverse cardiovascular event
timeFrame: 36 months after baseline
measure: Procedures
timeFrame: 36 months after baseline
measure: Radiation dose and incidental findings from CTCA
timeFrame: 36 months after baseline
measure: Change in quality of life (SF-12)
timeFrame: 36 months after baseline
measure: The primary outcome in different subgroups
timeFrame: 36 months after baseline
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute Of Medical Imaging Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
name: Trail Manager
role: STUDY_CHAIR
References: