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Dynamic Cardiac SPECT Imaging (SPECT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by University of California, San Francisco.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01934985
First Posted: September 4, 2013
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lawrence Berkeley National Laboratory (LBNL)
Information provided by (Responsible Party):
University of California, San Francisco
August 19, 2013
September 4, 2013
June 8, 2015
March 2012
September 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01934985 on ClinicalTrials.gov Archive Site
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Dynamic Cardiac SPECT Imaging
Dynamic Cardiac SPECT Imaging
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
University of California, San Francisco (UCSF) Cardiology Clinics
Coronary Artery Disease
Not Provided
  • 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.
  • Group III
    Patients found at SCA to have lesions of "borderline" clinical significance, preferably in the absence of other associated lesions.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
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September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01934985
5R01HL050663( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
Lawrence Berkeley National Laboratory (LBNL)
Principal Investigator: Elias Botvinick, MD University of California, San Francisco
University of California, San Francisco
June 2015