The Hybrid Combination of CCTA and SPECT and CAG for Evaluation Prognosis of CAD: an Observational Follow-up Study (HSCA)

September 24, 2020 updated by: Xu Zhihui, The First Affiliated Hospital with Nanjing Medical University

The First Affiliated Hospital of Nanjing Medical University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events (MACE)
Time Frame: 5 YEARS
All-cause death, cardiac death, ischemic stroke, unplanned revascularization and nonfatal myocardial infarction
5 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Changzhou No.2 People's Hospital
Huai'an First People's Hospital

Investigators

  • Study Chair: Yi Chai, MD, The First Affiliated Hospital Hospital of Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-SR-242
  • BK20141020 (Other Grant/Funding Number: Zhihui Xu)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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