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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554134
Other study ID # 2019-SR-242
Secondary ID BK20141020
Status Completed
Phase
First received
Last updated
Start date January 1, 2005
Est. completion date February 1, 2020

Study information

Verified date September 2020
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 550
Est. completion date February 1, 2020
Est. primary completion date January 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

1. Age: 18-70

2. Gender: All

3. coronary artery disease patients (CAD)

4. underwent CCTA, SPECT and coronary angiography (CAG) together within 3 months

5. Time: 2005-2015

Exclusion Criteria:

1. dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), congenital heart disease (CHD), atrial fibrillation (AF), ventricular tachycardia (VT)

2. Prior coronary revascularization;

3. permanent pacemaker or internal defibrillator

4. prosthetic heart valve

5. coronary image lose

6. coronary artery severe calcification

7. motion artifacts and poor CCTA image quality

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University Changzhou No.2 People's Hospital, Huai'an First People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events (MACE) All-cause death, cardiac death, ischemic stroke, unplanned revascularization and nonfatal myocardial infarction 5 YEARS
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