Dynamic Cardiac SPECT Imaging

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01934985

Collaborator

Lawrence Berkeley National Laboratory (LBNL) (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

122

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease

Study Design

Study Type:

Observational

Actual Enrollment :

83 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic Cardiac SPECT Imaging

Actual Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Coronary Flow Reserve [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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