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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • California
      • San Francisco, California, United States, 94107
        • University of California, San Francisco Imaging Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Length of procedure- 90 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Lawrence Berkeley National Laboratory (LBNL)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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