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

This study is currently recruiting participants.
Verified October 2016 by Yonsei University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680081
First Posted: September 6, 2012
Last Update Posted: October 19, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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 Intervention Phase
Coronary Artery Disease Other: Adenosine stress dynamic CT perfusion Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 152
Study Start Date: October 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT perfusion group Other: Adenosine stress dynamic CT perfusion

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01680081


Contacts
Contact: Byoung Wook Choi, MD 82-2-2228-7400 bchoi@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Byoung Wook Choi, MD    82-2228-7400    bchoi@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01680081     History of Changes
Other Study ID Numbers: 1-2011-0064
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: October 19, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
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