Adenosine-induced Stress Dynamic Myocardial Perfusion Ima... | NCT01680081

Studies
Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT

NCT01680081

Sponsor

Yonsei University

Status

Terminated

Last Update Posted

Jan 23, 2019Actual

Enrollment

51Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Adenosine stress dynamic CT perfusion

Countries

South Korea

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment of target subjects and difficulty registering subjects

Expanded Access Info

Start Date

Jan 30, 2012Actual

Primary Completion Date

Jul 11, 2016Actual

Completion Date

Jul 11, 2016Actual

First Submitted Date

Sep 3, 2012

First Submission Date that Met QC Criteria

Sep 5, 2012

First Posted Date

Sep 6, 2012Estimated

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

Jan 18, 2019

Last Update Posted Date

Jan 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study was designed as a prospective multicenter trial to determine the accuracy of combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic perfusion imaging in patients with suspicious coronary artery disease compared conventional coronary angiography and quantitative dynamic perfusion MRI as standard reference.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Label	Type	Description	Intervention Names
CT perfusion group	Experimental		Other: Adenosine stress dynamic CT perfusion

Name	Type	Description	Arm Group Labels	Other Names
Adenosine stress dynamic CT perfusion	Other		CT perfusion group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of stress induced CT perfusion	Diagnostic accuracy of combined stress and rest dynamic CT perfusion and coronary angiography with dual x-ray sources in detection of hemodynamically significant stenosis of coronary artery compared with conventional coronary angiography and perfusion MRI in patients with suspicious coronary artery disease.	10-30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women patients, with age ranging 40-80.
Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications
Patients who are willing to sign the informed consent form

Exclusion Criteria:

Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine(>1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min
Unstable or uncooperative patients
Limited life expectancy due to cancer or end-stage renal or liver disease
Evidence of severe symptomatic heart failure (NYHA Class III or IV)
Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Severance hospital		Seoul		120-752	South Korea

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