NCT01520025

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

3.1 years

First QC Date

July 15, 2011

Last Update Submit

April 21, 2017

Conditions

Myocardial Ischemia

Keywords

Radiopharmaceutical18FDG PETCTAMulti-modality imagingMetabolic Imaging of IschemiaMyocardial blood flowMyocardial blood flow reserve

Outcome Measures

Primary Outcomes (1)

  • Extent of ischemia as determined by visual and quantitative analysis

    at time of scan

Secondary Outcomes (1)

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

    3 to 9 months

Study Arms (1)

18F-FDG PET imaging

EXPERIMENTAL

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

Interventions

PET MPI imaging with 18F-FluorodeoxyglucoseRADIATION

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)

18F-FDG PET imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to undergo stress protocol due to co-morbidities
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (3)

  • 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.

    PMID: 10888390BACKGROUND

  • 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.

    PMID: 12939208BACKGROUND

  • 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.

    PMID: 17198348BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Terrence D Ruddy, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2011

First Posted

January 27, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

CA(1)