Health TrialsbyHealthPanel

PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques

ConditionsCoronary Arterial Disease (CAD)Coronary Arteriosclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

This is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Comprehensive morphological and functional plaque analysis will be performed. The impact of these morphological and functional parameters, alongside cardiometabolic factors and pharmacological treatments on plaque progression and the occurrence of major adverse cardiovascular events (MACEs) will be analyzed. In addition, intracoronary imaging techniques will be used to improve the accuracy of plaque analysis by coronary CTA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Clinically significant angina pectoris, or suspected CAD

Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries.

Disqualifiers

Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)

Receive percutaneous coronary intervention (PCI) within 6 months

Prior history of myocardial infarction or heart failure

Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

Trial population

This is a combination of retrospective and prospective cohort studies. Patients with clinical angina pectoris or suspected CAD who undergo coronary CTA scan, including outpatient and hospitalized patients, are consecutively enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50,000 Participants
are grouped into 1 trial group
Group A: PRACTICE cohort

Trial outcomes

Primary outcomes

1

Changes in total atheroma volume (TAV)

changes in TAV in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up

Time frame
24 months

Secondary outcomes

1

Major cardiovascular events (MACEs)

A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up

Time frame
5 years
2

Cardiovascular death

The occurrence of cardiovascular death during follow-up

Time frame
5 years
3

Myocardial infarction

The occurrence of myocardial infarction during follow-up

Time frame
5 years
4

Unplanned revascularization

The occurrence of unplanned revascularization during follow-up

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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