Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary Computed Tomography Angiography, Current clinical guidelines.
- Who it may be relevant to
- Registry conditions: Major Adverse Cardiovascular Events (MACE), Prevention, Coronary Artery Disease(CAD), CT Angiography. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial
Overview
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 multicenter, 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.
Interventions
- Diagnostic test 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. - Other Current clinical guidelines
Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
Primary outcome measures
- Major adverse cardiovascular and cerebrovascular event [Time frame: 36 months after baseline]
Secondary outcome measures (12)
- LDL-C control rate [Time frame: 12 months after baseline]
- Mean LDL-C changes [Time frame: 12 months after baseline]
- Adherence to lipid-lowering medication rate [Time frame: 12 months after baseline]
- The difference in healthcare-seeking rates between the two groups [Time frame: 12 months after baseline]
- Hypertension control rate [Time frame: 12 months after baseline]
- Diabetic control rate [Time frame: 12 months after baseline]
- Cardiac death [Time frame: 36 months after baseline]
- Fatal and non-fatal myocardial infarction or stroke [Time frame: 36 months after baseline]
- Rehospitalization due to progressive angina [Time frame: 36 months after baseline]
- Major adverse cardiovascular event [Time frame: 36 months after baseline]
- Procedures [Time frame: 36 months after baseline]
- Radiation dose and incidental findings from CTCA [Time frame: 36 months after baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Research Institute Of Medical Imaging Jinling Hospital — Nanjing
Identifiers
NCT: NCT06843005 · 2024DZKY-132-01