Clinical trial NCT01934985: Dynamic Cardiac SPECT Imaging
Official title: Dynamic Cardiac SPECT Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Single-Photon Emission-Computed Tomography
Myocardial Perfusion Imaging
Ischemia
Stress test
Coronary Artery Disease (CAD)
Coronary Flow Reserve (CFR)
Coronary Angiography
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Lawrence Berkeley National Laboratory (LBNL)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-09-04
Enrollment: 83
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of California, San Francisco (UCSF) Cardiology Clinics

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Coronary Flow Reserve
timeFrame: Length of procedure- 90 min
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Imaging Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Youngho Seo, Phd
role: PRINCIPAL_INVESTIGATOR
References: