NCT00074724

Brief Summary

To define the role of the assessment of myocardial viability with dobutamine echocardiography (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of patients with coronary artery disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable cardiovascular-diseases

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

May 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2003

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
4 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

June 1, 2016

Enrollment Period

5.6 years

First QC Date

December 19, 2003

Results QC Date

March 11, 2021

Last Update Submit

March 11, 2021

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart FailureHeart Failure, CongestiveHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Survival Free of Cardiac Hospitalization

    3 years

Secondary Outcomes (1)

  • Left Ventricular Ejection Fraction

    4 months and 2 years

Study Arms (2)

Medical Therapy

ACTIVE COMPARATOR

All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.

Drug: Modern medical managementDevice: Dobutamine echocardiographyDrug: Optimal medical therapy

CABG

ACTIVE COMPARATOR

Surgical revascularization in conjunction with optimal medical therapy.

Procedure: Coronary Artery BypassDevice: Dobutamine echocardiography

Interventions

Coronary Artery BypassPROCEDURE

coronary revascularization using arterial or vein conduits

Also known as: CABG
CABG
Modern medical managementDRUG

Therapies with evidence-based recommendations.

Also known as: Optimal medical therapy
Medical Therapy
Dobutamine echocardiographyDEVICE

Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.

Also known as: dobutamine echo
CABGMedical Therapy
Optimal medical therapyDRUG

All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.

Also known as: MOdern medical therapy
Medical Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic heart failure defined as NYHA Class II - IV (within 3 months of entry)
  • LV less than 35% defined by CMR or gated SPECT studies
  • Coronary anatomy suitable for revascularization

You may not qualify if:

  • Primary valvular heart disease clearly defined indicating the need for valve repair or replacement
  • Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support
  • PCI planned for CAD treatment
  • Acute myocardial infarction within 30 days
  • More than one prior cardiac operation
  • Non-cardiac illness with life expectancy of less than 3 years
  • Non-cardiac illness imposing substantial operative mortality. Patients eligible to enter the study will be further evaluated by the STICH team for SVR eligibility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart FailureHeart Diseases

Interventions

Coronary Artery BypassEchocardiography, Stress

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical ProceduresEchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Results Point of Contact

Title
Scientific Center Administrator
Organization
MedStar Health Research Institute
Research@medstar.net
301-560-7300

Study Officials

  • Julio Panza

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2003

First Posted

December 23, 2003

Study Start

May 1, 2003

Primary Completion

December 1, 2008

Study Completion

April 1, 2017

Last Updated

April 8, 2021

Results First Posted

April 8, 2021

Record last verified: 2016-06