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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01680081
First received: September 3, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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: August 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT perfusion group Other: Adenosine stress dynamic CT perfusion

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01680081     History of Changes
Other Study ID Numbers: 1-2011-0064
Study First Received: September 3, 2012
Last Updated: March 4, 2014
Health Authority: South Korea: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 28, 2014