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NCT Number: NCT06843005

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary Computed Tomography Angiography

Diagnostic Test

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

Current clinical guidelines

Other

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

Primary outcomes

  1. Major adverse cardiovascular and cerebrovascular event

    Time frame: 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 outcomes

  1. LDL-C control rate

    Time frame: 12 months after baseline

    The proportion of participants with controlled LDL-C(<1.4mmol/L)

  2. Mean LDL-C changes

    Time frame: 12 months after baseline

    Mean LDL-C changes of participants

  3. Adherence to lipid-lowering medication rate

    Time frame: 12 months after baseline

    The proportion of participants who adhere to lipid-lowering drugs

  4. The difference in healthcare-seeking rates between the two groups

    Time frame: 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

  5. Hypertension control rate

    Time frame: 12 months after baseline

    The proportion of participants with SBP<140mmHg and DBP<90mmHg.

  6. Diabetic control rate

    Time frame: 12 months after baseline

    The proportion of participants with HbA1c <53 mmol/mol (7.0%).

  7. Cardiac death

    Time frame: 36 months after baseline

    Number of participants diagnosed with cardiovascular death

  8. Fatal and non-fatal myocardial infarction or stroke

    Time frame: 36 months after baseline

    Number of participants diagnosed with myocardial infarction or stroke

  9. Rehospitalization due to progressive angina

    Time frame: 36 months after baseline

    Number of patients seeking medical care for unstable angina

  10. Major adverse cardiovascular event

    Time frame: 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

  11. Procedures

    Time frame: 36 months after baseline

    The proportion of participants undergone procedures,including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery

  12. Radiation dose and incidental findings from CTCA

    Time frame: 36 months after baseline

    The total radiation dose received by the participants during multiple examinations after enrollment.

  13. Change in quality of life (SF-12)

    Time frame: 36 months after baseline

    Change in quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument

  14. The primary outcome in different subgroups

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Longjiang Zhang, MD

CONTACT

[email protected]

13405833167

Sponsors and collaborators

Lead sponsor

Zhang longjiang,MD

Other

Registry information

Official study title

Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial

Acronym: SUCCESS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 24, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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