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

Primary Purpose

Myocardial Ischemia

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PET MPI imaging with 18F-Fluorodeoxyglucose
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring Radiopharmaceutical, 18FDG PET, CTA, Multi-modality imaging, Metabolic Imaging of Ischemia, Myocardial blood flow, Myocardial blood flow reserve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FDG PET imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

Extent of ischemia as determined by visual and quantitative analysis

Secondary Outcome Measures

The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET)

Full Information

First Posted
July 15, 2011
Last Updated
April 21, 2017
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01520025
Brief Title
Multi-modality Imaging of Ischemia With 18F-FDG PET and CTA
Official Title
Direct Imaging of Ischemia With 18F-FDG PET Imaging Combined With Coronary Anatomy From CT Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Continued recruitment of study participants was not feasible
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Radiopharmaceutical, 18FDG PET, CTA, Multi-modality imaging, Metabolic Imaging of Ischemia, Myocardial blood flow, Myocardial blood flow reserve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG PET imaging
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
PET MPI imaging with 18F-Fluorodeoxyglucose
Intervention Description
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 Measure Information:
Title
Extent of ischemia as determined by visual and quantitative analysis
Time Frame
at time of scan
Secondary Outcome Measure Information:
Title
The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET)
Time Frame
3 to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Age ≥ 18 years Exclusion Criteria: Inability to undergo stress protocol due to co-morbidities Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence D Ruddy, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10888390
Citation
Abramson BL, Ruddy TD, deKemp RA, Laramee LA, Marquis JF, Beanlands RS. Stress perfusion/metabolism imaging: a pilot study for a potential new approach to the diagnosis of coronary disease in women. J Nucl Cardiol. 2000 May-Jun;7(3):205-12. doi: 10.1016/s1071-3581(00)70008-0.
Results Reference
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PubMed Identifier
12939208
Citation
He ZX, Shi RF, Wu YJ, Tian YQ, Liu XJ, Wang SW, Shen R, Qin XW, Gao RL, Narula J, Jain D. Direct imaging of exercise-induced myocardial ischemia with fluorine-18-labeled deoxyglucose and Tc-99m-sestamibi in coronary artery disease. Circulation. 2003 Sep 9;108(10):1208-13. doi: 10.1161/01.CIR.0000088784.25089.D9. Epub 2003 Aug 25.
Results Reference
background
PubMed Identifier
17198348
Citation
Abbott BG, Liu YH, Arrighi JA. [18F]Fluorodeoxyglucose as a memory marker of transient myocardial ischaemia. Nucl Med Commun. 2007 Feb;28(2):89-94. doi: 10.1097/MNM.0b013e328013eaa5.
Results Reference
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Multi-modality Imaging of Ischemia With 18F-FDG PET and CTA

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