The Hybrid Combination of CCTA and SPECT and CAG for Eval... | NCT04554134

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

NCT04554134

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Completed

Last Update Posted

Sep 28, 2020Actual

Enrollment

550Actual

Phase

Not provided

Conditions

Coronary Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BK20141020	Other Grant/Funding Number	Zhihui Xu

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005Actual

Primary Completion Date

Jan 1, 2015Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Sep 14, 2020

First Submission Date that Met QC Criteria

Sep 17, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2020

Last Update Posted Date

Sep 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xu Zhihui, Director, The First Affiliated Hospital with Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Collaborators

Name	Class
Huai'an First People's Hospital	OTHER
Changzhou No.2 People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

550Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yi Chai, MD	The First Affiliated Hospital Hospital of Nanjing Medical University	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Aug 11, 2022
Reset	Jul 11, 2023
Release	Jul 13, 2023
Unrelease	Jul 14, 2023
Release	Jul 14, 2023
Reset	Feb 23, 2024

Submission Tracking

Estimated Results First Submitted Date

Aug 11, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 11, 2022			Jul 11, 2023
Jul 13, 2023	Jul 14, 2023

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided