- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934985
Dynamic Cardiac SPECT Imaging (SPECT)
August 5, 2022 updated by: University of California, San Francisco
The investigators propose a 4 year prospective, observational study of 40 patients yearly, comparing conventional clinically indicated SPECT and PET perfusion with dynamic rest/stress MPI studies with coronary angiography, in some cases performed with quantitative coronary anatomy and flow as well as quantitative 13N-ammonia PET MPI.
Methods will also be assessed for their ability to determine myocardial viability by comparing regional wall motion (WM) on clinically indicated serial ventriculography, echocardiography or gated SPECT MPI in those protocol patients with WM abnormalities who subsequently undergo revascularization.
Patient studies will begin in the first study year based on those methods already developed and integrate new advances as they become evident.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
83
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94107
- University of California, San Francisco Imaging Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
University of California, San Francisco (UCSF) Cardiology Clinics
Description
Inclusion Criteria:
- Patients who have had clinically indicated stress MPI with a low pre-test likelihood (0 - 15% ) of coronary disease based on the criteria of Diamond and Forrester.
- Patients who have already had a clinically indicated stress MPI in the last three years with a low likelihood of having active coronary disease with no significantly narrowed coronary arteries.
- Patients whose clinically indicated stress MPI demonstrates clear abnormalities and who are likely to go on to SCA for clinical indications.
- If, after conventional and dynamic MPI some of these patients do not have SCA, they will still be followed for events for up to 3 years following participation in the protocol. To avoid delays and unnecessary procedures among patients in Group II who will have the dynamic imaging protocol studies after SCA, patients will be selected for protocol enlistment only if the decision is made by the patient's physician, based totally on clinical and social factors, that any considered revascularization intervention would not be performed on the day of diagnostic SCA and will be performed electively, at least 4 to 7 days later.
- Patients found at SCA to have lesions of "borderline" clinical significance, preferably in the absence of other associated lesions.
Exclusion Criteria:
- Cannot give informed consent
- Unable or unwilling to return for a second stress imaging study
- Cannot cooperate for adequate SPECT or PET supine and/or prone imaging
- Pregnant females
- Patients under 21 years old
- Active bronchospasm - No theophylline for 48 hours prior to study
- Heart block more severe than Wenckebach block
- Patients with uncomplicated infarction will not be included if they cannot have an exercise test later than 8 weeks of the event or a vasodilator pharmacologic stress test at least 24 hours or more after the event
- Coronary bypass surgery within 8 weeks
- Symptoms of congestive heart failure at rest
- Has had an event or change in drug regimen since the initial stress test.
- Has serious response to or side effect from initial clinical stress test induced ST elevation, hypotension, prolonged arrhythmia, bronchospasm.
- Has had a clinical event since last coronary angiogram, angioplasty, or coronary surgery.
- Has had 201Tl rest SPECT MPI prior to dynamic imaging
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Patients scheduled to have clinically indicated stress MPI with low pre-test likelihood (0-15%) of coronary disease based on criteria of Diamond and Forrester.
And those who have already had a clinical indicated stress MPI in the last three years with a low likelihood of having active coronary disease with no significantly narrowed coronary arteries.
|
Group II
Patients in Group II who will have the dynamic imaging protocol studies after SCA, patients will be selected for protocol enlistment only if the decision is made by the patient's physician, based totally on clinical and social factors, that any considered revascularization intervention would not be performed on the day of diagnostic selective coronary angiography (SCA) and will be performed electively, at least 4 to 7 days later.
Viability will be assessed in these patients only in the presence of WM abnormalities, and with serial analysis of WM, as described above.
Patients will be followed for death or infarction or other events more than 3 months after study, for up to 3 years following participation in the protocol.
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Group III
Patients found at SCA to have lesions of "borderline" clinical significance, preferably in the absence of other associated lesions.
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Group IV
Patients who were diagnosed with advanced heart failure including patients who had or will have cardiac resynchonization therapy (CRT) or a heart transplant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronary Flow Reserve
Time Frame: Length of procedure- 90 min
|
The coronary flow reserve will be measured by comparing the rest and stress exams on the dynamic SPECT scans using developed algorithms.
The accuracy will be compared with clinical PET, coronary angiography, and clinical SPECT.
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Length of procedure- 90 min
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2012
Primary Completion (ACTUAL)
May 1, 2022
Study Completion (ACTUAL)
May 1, 2022
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (ESTIMATE)
September 4, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 9, 2022
Last Update Submitted That Met QC Criteria
August 5, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01HL050663 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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