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Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography

This study is currently recruiting participants.
Verified February 2013 by University of Edinburgh
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01368237
First received: June 6, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

Recent advances in technology have resulted in the development of scanners that can image the heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. Further advances in technology allow the visualisation of both the blood vessels and the supply of blood to the heart muscle. Here we propose to assess the latest and most powerful computed tomography scanner and compare it to magnetic resonance and conventional coronary angiography.


Condition Intervention
Coronary Heart Disease
 Radiation: Computed tomography scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The primary outcome measure is to establish whether 320-multidetector computed tomography can identify myocardial perfusion defects as compared to the gold standards of 3Tesla magnetic resonance imaging and fractional flow reserve measured during invasive coronary angiography.


Secondary Outcome Measures:
  • Identification of regional wall motion abnormalities qualitatively by trained observers [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of regional wall motion abnormalities in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.

  • Identification of infarction qualitatively by trained observers [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of infarction in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.

  • Identification of regional wall motion abnormalities quantitatively by computer software [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of regional wall motion abnormalities in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.

  • Identification of infarction qualitatively by computer software [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of infarction in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.


Estimated Enrollment: 75
Study Start Date: May 2006
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
Patients awaiting invasive coronary angiography
 Radiation: Computed tomography scan
Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and imaging of myocardial perfusion, function and viability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients awaiting invasive coronary angiography

Criteria

Inclusion Criteria:

  • referred for invasive coronary angiography because of suspected coronary heart disease

Exclusion Criteria:

  • inability or unwillingness to undergo computed tomography or magnetic resonance imaging
  • renal failure (serum creatinine >200 micromol/L or estimated glomerular filtration rate <30 mL/min)
  • hepatic failure
  • allergy to iodinated contrast or gadolinium
  • pregnancy
  • contraindication to adenosine infusion
  • inability to give informed consent
  • inability to perform fractional flow reserve during invasive coronary angiography
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368237

Contacts
Contact: Michelle C Williams, MBChB 01312426379 michelle.williams@ed.ac.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Scotland, United Kingdom
Contact: Michelle Williams, MBChB     01312426364     michelle.williams@ed.ac.uk    
Sub-Investigator: Michelle Williams, MBChB            
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: David E Newby University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01368237     History of Changes
Other Study ID Numbers: 210/R/CAR/11
Study First Received: June 6, 2011
Last Updated: February 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Computed tomography
Myocardial perfusion
Coronary heart disease

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 June 18, 2013