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

NCT01680081 | Terminated Phase 4

• 1 other identifier: 1-2011-0064
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CT perfusion group

EXPERIMENTAL

Other: Adenosine stress dynamic CT perfusion

Interventions

Adenosine stress dynamic CT perfusion OTHER

CT perfusion group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 6, 2012
• Study Start: January 30, 2012
• Primary Completion: July 11, 2016
• Study Completion: July 11, 2016
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

KR (1)