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Myocardial Stress Perfusion Imaging With Dual Source CT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00853671
First received: February 27, 2009
Last updated: April 30, 2010
Last verified: April 2010
History of Changes
  Purpose

The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.


Condition Intervention
Coronary Artery Disease
 Radiation: Cardiac CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Myocardial Stress Perfusion Imaging With Dual Source CT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To evaluate the diagnostic accuracy of Dual-Source Multi-Detector Computed Tomography (DSCT) in simultaneously detecting coronary stenosis and myocardial perfusion defects during pharmacological stress as compared to invasive angiography. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare areas of inducible ischemia and fixed defects between stress DSCT, Dual energy DSCT, and SPECT. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Cardiac CT
    Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; IV contrast- total dose of 150cc; CT radiation - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram
  • Age > 40 years old
  • Able to comprehend and sign the consent form.

Exclusion Criteria:

  • Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
  • Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
  • Premenopausal women who have a positive pregnancy test.
  • Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.
  • Known allergy to iodinated contrast agents
  • Atrial fibrillation
  • Asthma
  • Critical aortic stenosis
  • Systolic blood pressure < 90 mmHg
  • Advanced heart block
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853671

Contacts
Contact: Ricardo C Cury, MD 305-9877421 rcury@partners.org
Contact: Brian Ghoshhajra, MD 617-4168506 BGHOSHHAJRA@PARTNERS.ORG

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ricardo Cury, MD     305-987-7412     rcury@partners.org    
Contact: Brian Ghoshhajra, MD     617-4168506     BGHOSHHAJRA@PARTNERS.ORG    
Sponsors and Collaborators
Massachusetts General Hospital
Astellas Pharma Inc
Investigators
Principal Investigator: Ricardo C Cury, MD Massachusetts General Hospital, Baptist Hospital, Miami
Study Director: Brian Ghoshhajra, MD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Ricardo Cury, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853671     History of Changes
Other Study ID Numbers: DSCTSTRESS
Study First Received: February 27, 2009
Last Updated: April 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Coronary Artery Disease
Multidetector Computed Tomography
Myocardial Perfusion Imaging

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

ClinicalTrials.gov processed this record on May 19, 2013