NCT04554134

Brief Summary

A total of 550 patients with stable angina (40-70% stenosis) tested by coronary CT angiography (CCTA) and single photon emission computed tomography (SPECT) and coronary angiography (CAG) within 3 months were retrospectively recruited from 2005 to 2015 and follow up to 5 years. A new hybrid software was used to analysis the image data.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2005

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

10 years

First QC Date

September 14, 2020

Last Update Submit

September 24, 2020

Conditions

Keywords

SPECTCCTACAGHybrid

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events (MACE)

    All-cause death, cardiac death, ischemic stroke, unplanned revascularization and nonfatal myocardial infarction

    5 YEARS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were suspected coronary artery disease and underwent CCTA, SPECT and CAG within 3 months from 2005 to 2015.

You may qualify if:

  • Age: 18-70
  • Gender: All
  • coronary artery disease patients (CAD)
  • underwent CCTA, SPECT and coronary angiography (CAG) together within 3 months
  • Time: 2005-2015

You may not qualify if:

  • dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), congenital heart disease (CHD), atrial fibrillation (AF), ventricular tachycardia (VT)
  • Prior coronary revascularization;
  • permanent pacemaker or internal defibrillator
  • prosthetic heart valve
  • coronary image lose
  • coronary artery severe calcification
  • motion artifacts and poor CCTA image quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yi Chai, MD

    The First Affiliated Hospital Hospital of Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

January 1, 2005

Primary Completion

January 1, 2015

Study Completion

February 1, 2020

Last Updated

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

The hybrid software will be uploaded to the open internet. Cardiologist could upload their patients' image data and the hybrid results will be proved.