Natural History of Coronary Atherosclerosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

The present study sought to explore the predictive value of radial wall strain (RWS, derived solely from angiograms) for coronary artery lesion progression compared with lesion vulnerability assessed by optical coherence tomography (OCT). The lesion progression at 1 year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary angiography (QCA) evaluation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Acute myocardial infarction ≤ 45 days

Planned coronary angiography examination or potential interventional treatment

The presence of at least 1 non-flow-restricting lesion (visually estimated diameter stenosis: 30%-80%; QFR > 0.80) in any non-infarct related artery with RVD ≥2.5 mm by visual assessment

Disqualifiers

Cardiogenic shock

Pregnant or woman of child-bearing potential

Life expectancy less than 1 year for non-cardiac causes

Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy

Trial population

Adult study participants with acute myocardial infarction complicated by multi-vessel coronary artery diseases within 45 days.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Lesion progression assessed by QCA

Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation

Time frame
1 year

Secondary outcomes

1

Incidence of major adverse cardiac events (MACE)

Defined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization

Time frame
1 year, 2 years, 3 years
2

Incidence of all-cause death

Including cardiac or non-cardiac death

Time frame
1 year, 2 years, 3 years
3

Incidence of new myocardial infarction

Time frame
1 year, 2 years, 3 years
4

Incidence of unplanned revascularization

Including infarction-related/non-infarction-related vessel revascularization

Time frame
1 year, 2 years, 3 years

Other outcomes

Sponsors and contacts

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