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
  Purpose

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 Intervention Phase
Myocardial Ischemia
Radiation: PET MPI imaging with 18F-Fluorodeoxyglucose
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Direct Imaging of Ischemia With 18F-FDG PET Imaging Combined With Coronary Anatomy From CT Coronary Angiography

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Extent of ischemia as determined by visual and quantitative analysis [ Time Frame: at time of scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: December 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01520025

Contacts
Contact: Marlie Poirier, BScN, CCRP 613-761-5103 mpoirier@ottawaheart.ca
Contact: Brian Marvin, NMT 613-761-5103 bmarvin@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Marlie Poirier, BScN CCRP    613-761-5103    mpoirier@ottawaheart.ca   
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Principal Investigator: Terrence D Ruddy, MD University of Ottawa Heart Institute
  More Information

Publications:
Responsible Party: Terrence Ruddy, Principal Investigator, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01520025     History of Changes
Other Study ID Numbers: HI Protocol #2011397-01H
Study First Received: July 15, 2011
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
Radiopharmaceutical
18FDG PET
CTA
Multi-modality imaging
Metabolic Imaging of Ischemia
Myocardial blood flow
Myocardial blood flow reserve

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014