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

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ClinicalTrials.gov Identifier: NCT01680081
Recruitment Status : Terminated (Slow recruitment of target subjects and difficulty registering subjects)
First Posted : September 6, 2012
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE January 30, 2012
Actual Primary Completion Date July 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Diagnostic accuracy of stress induced CT perfusion [ Time Frame: 10-30 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01680081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT
Official Title  ICMJE Not Provided
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Other: Adenosine stress dynamic CT perfusion
Study Arms  ICMJE Experimental: CT perfusion group
Intervention: Other: Adenosine stress dynamic CT perfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 18, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
152
Actual Study Completion Date  ICMJE July 11, 2016
Actual Primary Completion Date July 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)
  2. Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min
  3. Unstable or uncooperative patients
  4. Limited life expectancy due to cancer or end-stage renal or liver disease
  5. Evidence of severe symptomatic heart failure (NYHA Class III or IV)
  6. Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680081
Other Study ID Numbers  ICMJE 1-2011-0064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP