Coronary Artery Disease(CAD), CT Angiography, Major Adverse Cardiovascular Events (MACE), Prevention
Conditions
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 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_TESTCoronary 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.
OTHERCurrent clinical guidelines
Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
Sponsors
Zhang longjiang,MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event | 36 months after baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C control rate | 12 months after baseline | The proportion of participants with controlled LDL-C（\<1.4mmol/L） |
| Mean LDL-C changes | 12 months after baseline | Mean LDL-C changes of participants |
| Adherence to lipid-lowering medication rate | 12 months after baseline | The proportion of participants who adhere to lipid-lowering drugs |
| The difference in healthcare-seeking rates between the two groups | 12 months after baseline | The difference in healthcare-seeking rates between the two groups of patients, including both regular follow-ups and visits driven by clinical symptoms of coronary heart disease |
| Hypertension control rate | 12 months after baseline | The proportion of participants with SBP\<140mmHg and DBP\<90mmHg. |
| Diabetic control rate | 12 months after baseline | The proportion of participants with HbA1c \<53 mmol/mol (7.0%). |
| Cardiac death | 36 months after baseline | Number of participants diagnosed with cardiovascular death |
| Fatal and non-fatal myocardial infarction or stroke | 36 months after baseline | Number of participants diagnosed with myocardial infarction or stroke |
| Rehospitalization due to progressive angina | 36 months after baseline | Number of patients seeking medical care for unstable angina |
| Major adverse cardiovascular event | 36 months after baseline | Record the number of participants experiencing major adverse cardiovascular events such as all-cause mortality, non-fatal myocardial infarction and ischemia driven revascularation |
| Procedures | 36 months after baseline | The proportion of participants undergone procedures，including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery |
| Radiation dose and incidental findings from CTCA | 36 months after baseline | The total radiation dose received by the participants during multiple examinations after enrollment. |
| Change in quality of life (SF-12) | 36 months after baseline | Change in quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument |
| The primary outcome in different subgroups | 36 months after baseline | The primary outcome (all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke) will be analyzed in prespecified subgroups, including age, sex, hypertension, diabetes mellitus, degree of stenosis on baseline CCTA. |
Countries
China
Contacts
CONTACTLongjiang Zhang, MD
STUDY_CHAIRTrail Manager
Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
Outcome results
None listed