Back to results

Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Myocardial perfusion imaging

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of coronary artery disease
New or worsening symptoms
Out-patients and in-hospital patients

Exclusion Criteria:

Creatinine above 2.5 mg%
PCI within prior 6 months
Pregnant females
Cardiomyopathy (LVEF below 40%)
Significant valvular heart disease
Body mass index greater than 38

Sites / Locations

Saint Luke's Cardiovascular Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

SPECT myocardial perfusion imaging

PET myocardial perfusion imaging

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic failure of SPECT vs PET

Secondary Outcome Measures

Composite of diagnostic or clinical failure

Each of individual components of clinical failure

Relative effect on quality of life

Relative direct and downstream costs

Full Information

NCT ID

NCT00976053

First Posted

September 11, 2009

Last Updated

October 30, 2014

Sponsor

Aspire Foundation

Collaborators

Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute

1. Study Identification

Unique Protocol Identification Number

NCT00976053

Brief Title

Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

Official Title

Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aspire Foundation

Collaborators

Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

330 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPECT myocardial perfusion imaging

Arm Type

Active Comparator

Arm Title

PET myocardial perfusion imaging

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Myocardial perfusion imaging

Intervention Description

Randomization assignment to one of SPECT or PET myocardial perfusion imaging

Primary Outcome Measure Information:

Title

Diagnostic failure of SPECT vs PET

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Composite of diagnostic or clinical failure

Time Frame

12 months

Title

Each of individual components of clinical failure

Time Frame

12 months

Title

Relative effect on quality of life

Time Frame

3 months, 6 months

Title

Relative direct and downstream costs

Time Frame

3 months, 6 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of coronary artery disease New or worsening symptoms Out-patients and in-hospital patients Exclusion Criteria: Creatinine above 2.5 mg% PCI within prior 6 months Pregnant females Cardiomyopathy (LVEF below 40%) Significant valvular heart disease Body mass index greater than 38

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy M Bateman, M.D.

Organizational Affiliation

Aspire Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Luke's Cardiovascular Consultants

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31326480

Citation

Patel KK, Al Badarin F, Chan PS, Spertus JA, Courter S, Kennedy KF, Case JA, McGhie AI, Heller GV, Bateman TM. Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients. JACC Cardiovasc Imaging. 2019 Sep;12(9):1821-1831. doi: 10.1016/j.jcmg.2019.04.020. Epub 2019 Jul 17.

Results Reference

derived

Learn more about this trial

Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

We'll reach out to this number within 24 hrs