Dynamic Cardiac SPECT Imaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Lawrence Berkeley National Laboratory (LBNL)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01934985
First received: August 19, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Cardiac SPECT Imaging

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Coronary Flow Reserve [ Time Frame: Length of procedure- 90 min ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: March 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University of California, San Francisco (UCSF) Cardiology Clinics

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934985

Locations
United States, California
University of California, San Francisco Imaging Center Recruiting
San Francisco, California, United States, 94107
Contact: Emily Verdin, BA    415-353-9437    emily.verdin@ucsf.edu   
Principal Investigator: Elias Botvinick, MD         
Sponsors and Collaborators
University of California, San Francisco
Lawrence Berkeley National Laboratory (LBNL)
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01934985     History of Changes
Other Study ID Numbers: 5R01HL050663
Study First Received: August 19, 2013
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Single-Photon Emission-Computed Tomography
Myocardial Perfusion Imaging
Ischemia
Stress test
Coronary Artery Disease (CAD)
Coronary Flow Reserve (CFR)
Coronary Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014