Myocardial IschemiaPhase 4NCT01520025
Multi-modality Imaging of Ischemia With 18F-FDG PET and CTA
A Phase 4 study testing PET MPI imaging with 18F-Fluorodeoxyglucose in people with Myocardial Ischemia, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- PET MPI imaging with 18F-Fluorodeoxyglucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to undergo stress protocol due to co-morbidities
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- PET MPI imaging with 18F-Fluorodeoxyglucose
- Keywords
- Radiopharmaceutical, 18FDG PET, CTA, Multi-modality imaging, Metabolic Imaging of Ischemia, Myocardial blood flow, Myocardial blood flow reserve
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: PET MPI imaging with 18F-Fluorodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of ischemia as determined by visual and quantitative analysis
Measured: at time of scan
Secondary outcomes (1)
The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET)
Measured: 3 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Continued recruitment of study participants was not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence D Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520025
- Sponsor's protocol ID
- HI Protocol #2011397-01H
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2011
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10888390He 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.
PubMed 12939208Abbott 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.
PubMed 17198348
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Imaging of Ischemia With 18F-FDG PET Imaging Combined With Coronary Anatomy From CT Coronary Angiography
- ClinicalTrials.gov ID
- NCT01520025
- Acronym / sponsor ID
- HI Protocol #2011397-01H
- Conditions
- Myocardial Ischemia
- Keywords
- Radiopharmaceutical, 18FDG PET, CTA, Multi-modality imaging, Metabolic Imaging of Ischemia, Myocardial blood flow, Myocardial blood flow reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Continued recruitment of study participants was not feasible
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET imaging | Experimental | Radiation: PET MPI imaging with 18F-FluorodeoxyglucosePositron 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to undergo stress protocol due to co-morbidities
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET MPI imaging with 18F-FluorodeoxyglucoseExercise 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) | Radiation | 18F-FDG PET imaging |
Primary outcome
Extent of ischemia as determined by visual and quantitative analysis
Time frame: at time of scan
1 secondary outcome
The degree of correlation between the multiple modalities (CTAm stress PET or SPECT and 18FDG PET)
Time frame: 3 to 9 months
Results and safety
The study was stopped early (reason given: Continued recruitment of study participants was not feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Background: PubMed 10888390Abramson 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.
- Background: PubMed 12939208He 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.
- Background: PubMed 17198348Abbott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence D Ruddy, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PET MPI imaging with 18F-Fluorodeoxyglucose in people with Myocardial Ischemia, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Continued recruitment of study participants was not feasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of ischemia as determined by visual and quantitative analysis (time frame: at time of scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01520025, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.