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Multi-modality Imaging of Ischemia With 18F-FDG PET and CTA

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. Read our disclaimer for details. Identifier: NCT01520025
Recruitment Status : Terminated (Continued recruitment of study participants was not feasible)
First Posted : January 27, 2012
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation

Brief Summary:
Coronary artery disease results in narrowing of the blood vessels supplying oxygenated blood to the heart muscle. Diagnosis in patients with symptoms of chest pain is now quickly done with CT coronary angiography. This x-ray test can show narrowed blood vessels but has limited ability to predict the severity of the narrowings in some cases. We have described a new approach using PET exercise 18F-FDG imaging as a method to image areas of heart muscle not getting enough blood during exercise stress. The 18F-FDG images are co-registered with the CT anatomy from the CTA to provide direct evidence of the consequences of the narrowing.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Radiation: PET MPI imaging with 18F-Fluorodeoxyglucose Phase 4

Detailed Description:

The Investigators and others have demonstrated direct imaging of myocardial ischemia using 18F-Fluorodeoxyglucose (18FDG) with exercise or dipyridamole stress and positron emission tomography (PET) or single photon emission computed tomography (SPECT). This approach with "hot-spot" imaging may have greater diagnostic accuracy for ischemia than conventional "cold-spot" myocardial perfusion imaging.

Recent advances in multi-modality imaging permit fusion of CTA images with PET or SPECT perfusion images and functional assessment of anatomical CAD. Registration of the 2 data sets can be optimized using the CT acquired with the PET or SPECT15. 18FDG uptake as a marker for ischemia can be directly related to the coronary anatomy and guide revascularization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Direct Imaging of Ischemia With 18F-FDG PET Imaging Combined With Coronary Anatomy From CT Coronary Angiography
Study Start Date : December 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 18F-FDG PET imaging
Positron Emission Tomography nuclear stress scan following either pharmacologic or treadmill stress test with radiopharmaceutical injection at peak stress or within 1 hour following peak stress.
Radiation: PET MPI imaging with 18F-Fluorodeoxyglucose

Exercise Stress Testing. All patients will undergo a symptom-limited exercise treadmill test using the Bruce protocol after a 24 hour high fat, low carbohydrate diet and an overnight fast. Persantine Stress Testing: Subjects who have undergone Persantine stress protocol for the PET or SPECT will follow the same protocol. A high fat, low carbohydrate diet for 24 hours and a 12 hour overnight fast will precede the study stress scan. Anti-anginal medications will be withheld on the morning of the exercise test.

18FDG (370 mBq) will be injected at either peak exercise or within 1 hour of peak.

Patients will be imaged 60 minutes after radiotracer injection in the supine position in a Discovery 690/VCTLYSO PET system (GE Healthcare, Milwaukee, Wisconsin)

Primary Outcome Measures :
  1. Extent of ischemia as determined by visual and quantitative analysis [ Time Frame: at time of scan ]

Secondary Outcome Measures :
  1. The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET) [ Time Frame: 3 to 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patients with suspected CAD referred for CTA and found to have moderate CAD stenoses and 20 normal volunteers with less than 5% probability of CAD.
  2. Age ≥ 18 years

Exclusion Criteria:

  1. Inability to undergo stress protocol due to co-morbidities
  2. Pregnancy

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 identifier (NCT number): NCT01520025

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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
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Principal Investigator: Terrence D Ruddy, MD Ottawa Heart Institute Research Corporation

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Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation Identifier: NCT01520025    
Other Study ID Numbers: HI Protocol #2011397-01H
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
Multi-modality imaging
Metabolic Imaging of Ischemia
Myocardial blood flow
Myocardial blood flow reserve
Additional relevant MeSH terms:
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Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action