NCT06794684

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2016May 2030

Study Start

First participant enrolled

January 1, 2016

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

11.4 years

First QC Date

January 14, 2025

Last Update Submit

January 21, 2025

Conditions

Coronary Arterial Disease (CAD)Coronary Arteriosclerosis

Keywords

Coronary CTAPlaque Progressioncoronary artery diseasehigh-risk plaquesplaque compositionintracoronary imaging

Outcome Measures

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

    24 months

Secondary Outcomes (13)

  • Major cardiovascular events (MACEs)

    5 years

  • Cardiovascular death

    5 years

  • Myocardial infarction

    5 years

  • Unplanned revascularization

    5 years

  • Changes in calcified plaque volume

    24 months

  • +8 more secondary outcomes

Study Arms (1)

PRACTICE cohort

Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • Abnormal liver function (serum alanine aminotransferase \[ALT\] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30 ml/min)
  • Familial hypercholesterolemia
  • Estimated survival ≤ 1 year
  • Malignant tumor
  • Pregnant or lactation, or have the intention to give birth within one year
  • Poor coordinance, unable to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital

Shanghai, 200000, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample at baseline and follow-up

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ruiyan Zhang, M.D., Ph.D.

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqun Wang

CONTACT

+86 21 64370045 671605wangxq@shsmu.edu.cn

Shuo Feng

CONTACT

+86 21 64370045 671603fengshuorv@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 27, 2025

Study Start

January 1, 2016

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2030

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

CN(2)