Quantitative Analysis of Functional CT Imaging of Coronar... | NCT04986410

Studies
Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

NCT04986410

Sponsor

Qilu Hospital of Shandong University

Status

Completed

Last Update Posted

Aug 2, 2021Actual

Enrollment

640Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

CCTA, CT-MPI, CT-FFR, SPECT-MPI

Countries

China

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

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

Jul 1, 2017Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 11, 2021

First Submission Date that Met QC Criteria

Jul 22, 2021

First Posted Date

Aug 2, 2021Actual

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

Jul 22, 2021

Last Update Posted Date

Aug 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD.

Detailed Description

Coronary CT angiography (CCTA) has become a reliable diagnostic technique to evaluate coronary artery disease (CAD) with high sensitivity and a negative predictive value. However, CCTA provides only anatomic information and tends to overestimate stenosis severity and is limited in its ability to diagnose myocardial ischemia. Undertaking additional CT myocardial perfusion imaging(CT-MPI) and CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD. SPECT myocardial perfusion imaging (SPECT-MPI)and invasively measured fractional flow reserve (FFR) will serve as the reference standard.

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

640Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myocardial Perfusion examination			Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCTA, CT-MPI, CT-FFR, SPECT-MPI	Diagnostic Test	Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI	Myocardial Perfusion examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiovascular Events	including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic performance of CT-MPI	Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-perfusion imaging (quantitative and qualitative analysis) to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR and SPECT-MPI.	From admission to discharge, up to 1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Understand the purpose of the trial, voluntarily participate in this study, and have signed an informed consent form.
Patients with known or suspected CAD

Exclusion Criteria:

Patients with acute coronary syndrome.
Severe cardiac dysfunction (LVEF ≤ 0.3).
Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis.
Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis.
Severe hepatic and renal dysfunction (ALT ≥ 3 Upper Limit of Normal, Cr> 134μ/mol/L (2mg/dl) or estimated Glomerular Filtration Rate<45ml/min/1.73m2).
Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.)
Malignancy or other pathophysiological conditions with an expected survival of less than 1 year
Allergic to the drug components involved in this study and those who are intolerant to loading tests
Pregnant or lactating women.
Mental disorders.
Failure to sign the informed consent form.
Other conditions that are incompatible with the clinical study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with known or suspected CAD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mei Zhang	Qilu Hospital of Shandong University	Study Chair
Mei Zhang	Qilu Hospital of Shandong University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University		Jinan	Shandong	250012	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided