NCT00976053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

4.3 years

First QC Date

September 11, 2009

Last Update Submit

October 30, 2014

Conditions

Coronary Artery Disease

Keywords

Myocardial perfusion imagingSingle photon emission computed tomographyPositron emission tomography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic failure of SPECT vs PET

    60 days

Secondary Outcomes (4)

  • Composite of diagnostic or clinical failure

    12 months

  • Each of individual components of clinical failure

    12 months

  • Relative effect on quality of life

    3 months, 6 months

  • Relative direct and downstream costs

    3 months, 6 months, 12 months

Study Arms (2)

SPECT myocardial perfusion imaging

ACTIVE COMPARATOR
Procedure: Myocardial perfusion imaging

PET myocardial perfusion imaging

ACTIVE COMPARATOR
Procedure: Myocardial perfusion imaging

Interventions

Myocardial perfusion imagingPROCEDURE

Randomization assignment to one of SPECT or PET myocardial perfusion imaging

PET myocardial perfusion imagingSPECT myocardial perfusion imaging

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Cardiovascular Consultants

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

  • 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.

    PMID: 31326480DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Timothy M Bateman, M.D.

    Aspire Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator/Medical Director

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2013

Study Completion

October 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

US(1)