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

ConditionsMajor Adverse Cardiovascular Events (MACE)PreventionCoronary Artery Disease(CAD)CT Angiography
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhang longjiang,MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

3,100 Participants
are divided into 2 treatment groups
Group A: CCTA-based follow-up management groupActive comparator 1 intervention
Group B: clinical-based follow-up management groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular and cerebrovascular event

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

Time frame
36 months after baseline

Secondary outcomes

1

LDL-C control rate

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

Time frame
12 months after baseline
2

Mean LDL-C changes

Mean LDL-C changes of participants

Time frame
12 months after baseline
3

Adherence to lipid-lowering medication rate

The proportion of participants who adhere to lipid-lowering drugs

Time frame
12 months after baseline
4

The difference in healthcare-seeking rates between the two groups

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

Time frame
12 months after baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhang longjiang,MD

Lead sponsor

Jinling Hospital, China

Sponsor institution

Source ClinicalTrials.gov
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