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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Adenosine stress dynamic CT perfusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : January 30, 2012
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : July 11, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: CT perfusion group Other: Adenosine stress dynamic CT perfusion

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01680081

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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University Identifier: NCT01680081     History of Changes
Other Study ID Numbers: 1-2011-0064
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action