Myocardial Blood Flow by 15O Water PET

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Edinburgh
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01805193
First received: February 4, 2013
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

Coronary heart disease is a very common condition caused by narrowings in the blood vessel supplying the heart. the investigators are studying new tests to diagnose heart disease. In this study the investigators plan to investigate a special scan called a PET/CT (Positron emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to tell us about the flow of blood to the heart muscle.


Condition Intervention
Coronary Heart Disease
Other: Computed tomography myocardial perfusion imaging
Other: Oxygen 15 labelled water positron emission tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Computed Tomography Myocardial Perfusion Imaging Using Quantification of Myocardial Blood Flow by Positron Emission Tomography With 15O-water

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Myocardial blood flow [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography


Secondary Outcome Measures:
  • Fractional flow reserve [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Fractional flow reserve measured during invasive coronary angiography

  • Myocardial perfusion [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Myocardial perfusion measured as hypoperfusion on adenosine computed tomography myocardial perfusion imaging


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suspected coronary heart disease Other: Computed tomography myocardial perfusion imaging Other: Oxygen 15 labelled water positron emission tomography

Detailed Description:

Participants will undergo PET/CT with oxygen-15 labelled water and computed tomography myocardial perfusion imaging.

  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

Outpatients with suspected coronary heart disease

Criteria

Inclusion Criteria:

  • suspected coronary artery disease

Exclusion Criteria:

  • inability or unwillingness to undergo CT or PET imaging
  • renal failure (serum creatinine >200 um/L or eGFR <30 ml/min)
  • hepatic failure
  • allergy to iodinated contrast
  • pregnancy
  • contraindication to adenosine
  • inability to give informed consent
  • atrial fibrillation with a fast ventricular rate (>70 beats per minute)
  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: NCT01805193

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

Locations
United Kingdom
Clinical Research Imaging Centre Recruiting
Edinburgh, Scotland, United Kingdom
Contact: Michelle Williams, MBCHb       michelle.williams@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: David Newby, PhD DM University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01805193     History of Changes
Other Study ID Numbers: 12/SS/0078
Study First Received: February 4, 2013
Last Updated: March 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Coronary heart disease
computed tomography myocardial perfusion
positron emission tomography
oxygen 15 labelled water
myocardial perfusion
myocardial blood flow

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

ClinicalTrials.gov processed this record on October 02, 2014