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

Phase 4

Terminated

• Conditions: Myocardial Ischemia
• Interventions: Radiation: PET MPI imaging with 18F-Fluorodeoxyglucose

• Registration Number: NCT01520025
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2011-07-15
• Study Start: 2011-12
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-27
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FDG PET imaging	PET MPI imaging with 18F-Fluorodeoxyglucose	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.

Primary Outcome Measures

Name	Time	Method
Extent of ischemia as determined by visual and quantitative analysis	at time of scan

Secondary Outcome Measures

Name	Time	Method
The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET)	3 to 9 months

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada