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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Ottawa Heart Institute
Sponsor:
Information provided by (Responsible Party):
Terrence Ruddy, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01520025
First received: July 15, 2011
Last updated: March 14, 2014
Last verified: March 2014

July 15, 2011
March 14, 2014
December 2011
November 2014   (final data collection date for primary outcome measure)
Extent of ischemia as determined by visual and quantitative analysis [ Time Frame: at time of scan ] [ Designated as safety issue: No ]
Extent of ischemia as determined by visual and quantitative analysis [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01520025 on ClinicalTrials.gov Archive Site
The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET) [ Time Frame: 3 to 9 months ] [ Designated as safety issue: No ]
The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Multi-modality Imaging of Ischemia With 18F-FDG PET and CTA
Direct Imaging of Ischemia With 18F-FDG PET Imaging Combined With Coronary Anatomy From CT Coronary Angiography

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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Myocardial Ischemia
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)

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.
Intervention: Radiation: PET MPI imaging with 18F-Fluorodeoxyglucose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
November 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Marlie Poirier, BScN, CCRP 613-761-5103 mpoirier@ottawaheart.ca
Contact: Brian Marvin, NMT 613-761-5103 bmarvin@ottawaheart.ca
Canada
 
NCT01520025
HI Protocol #2011397-01H
No
Terrence Ruddy, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
Principal Investigator: Terrence D Ruddy, MD University of Ottawa Heart Institute
University of Ottawa Heart Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP