NCT07536607

Brief Summary

For patients with severe calcification or complex non-calcified plaques, we investigate wether PCCT can enable non-invasive, in vivo precise differentiation and quantitative measurement of plaque components (e.g., spotty calcification, necrotic core, fibrous tissue). Further we also study wether these quantitative imaging features can independently predict the risk of MACE in the short term and long term

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 11, 2026

Last Update Submit

April 11, 2026

Conditions

Coronary Artery Disease

Keywords

photon-counting detector CTcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events, MACE

    Non-fatal myocardial infarction Non-fatal stroke Cardiovascular death Revascularization Acute heart failure

    12months

Study Arms (1)

coronary artery disease patients referred to photon-counting CT examination

coronary artery disease patients who underwent photon-counting CT will be enrolled, a sub-specialty trained cardiac radiologist and a sub-specialty trained cardiologist will analyze the image from the photon counting CT scans in detail.

Other: there is no intervention in this study

Interventions

there is no intervention in this studyOTHER

there is no intervention

coronary artery disease patients referred to photon-counting CT examination

Eligibility Criteria

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

coronary artery disease patients referred to photon-counting CT examination

You may not qualify if:

  • History of iodine contrast agent allergy.
  • Severe renal insufficiency (eGFR \< 30 mL/min/1.73 m²).
  • History of prior coronary artery bypass grafting (CABG).
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jing ma, PhD,MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jing ma, PhD, MD, PhD,MD

CONTACT

+86 13681257396crystalma@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)