DECIPHER: Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00074724
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 319
• Arms: 2
• Actual Duration (Months): 167

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Coronary Disease; Heart Failure; Heart Failure, Congestive; Heart Diseases	Procedure: Coronary Artery Bypass; Drug: Modern medical management; Device: Dobutamine echocardiography; Drug: Optimal medical therapy	N/A

Detailed Description

BACKGROUND:

The number of individuals presenting with coronary artery disease (CAD) with impaired left ventricular (LV) function (measured as ejection fraction <35%), and clinical evidence of heart failure (HF) continues to increase. Patients with these conditions face the need for continuous and intensive medical management and poor quality of life. The STICH trial is designed to compare medical management to surgical revascularization in these patients. STICH's design includes myocardial function determination by several methods. The timely and important question of myocardial viability when function is poor is being examined using radionuclide methods. However, there is no consensus on the best technique to determine myocardial viability, or data to support this assessment as a potential determinant of prognosis following surgery. DECIPHER STICH adds dobutamine echocardiography (DE) for myocardial viability measurement to the parent trial. The study is of significance by addressing an important question and adding data for a technique that bears approximately half the cost of radionuclide methods. Furthermore, the revised design will allow for randomized and blinded evaluations of different treatment modalities according to myocardial viability determined by two different techniques.

DESIGN NARRATIVE:

The Dobutamine Echocardiography in Patients with Ischemic Heart failure Evaluated for Revascularization Study, as part of the Surgical Treatment for Ischemic Heart Failure Trial (DECIPHER-STICH), is designed to address the hypothesis that assessment of myocardial viability with dobutamine echocardiography (DE) in patients with coronary artery disease (CAD), left ventricular (LV) dysfunction and heart failure (HF) identifies the patients who derive the greatest survival benefit from surgical revascularization over medical therapy. In addition, this study will determine the value of DE for the prediction of recovery of LV function following revascularization, the clinical value of DE relative to that of radionuclide techniques used for the same purpose, and the relationship between abnormal LV size and shape and the contractile reserve of dysfunctional myocardium.

DECIPHER-STICH is an ancillary study to the large-scale STICH trial, a multicenter international randomized study designed to define the role of coronary artery bypass grafting (CABG) and surgical ventricular restoration (SVR) in the treatment of HF in patients with CAD and LV dysfunction. In previous studies, DE has compared favorably to other methods for the detection of viable myocardium. The widespread availability of echocardiography and the possibility of simultaneously deriving information about structural abnormalities (e.g., thrombi), valve function, and intracardiac pressures in addition to the real-time assessment of regional and global systolic function make DE particularly useful for the comprehensive evaluation of CAD patients with LV dysfunction. Because patients in the STICH trial will also undergo radionuclide tests, the DECIPHER-STICH study will allow a comparison of the most commonly used techniques for assessment of myocardial viability. Patients recruited into the STICH trial will be invited to participate in the DECIPHER-STICH study and asked to sign a separate consent form prior to the randomized assignment of therapy. Forty centers from North America and Europe recruiting patients into the STICH trial have agreed to take part in the DECIPHER-STICH study. A total of 1,450 of the 2,800 patients enrolled into the STICH trial will undergo DE prior to treatment. DECIPHER-STICH will address the hypothesis of greater beneficial effect of coronary artery bypass surgery (CABG) over medical therapy alone on 3-year survival rate with 80% power to detect a 25%-to-12.5% reduction in all-cause mortality in patients with viable myocardium. In addition, the study will have >99% power to address three important secondary hypotheses. The results of this study will provide definitive information regarding the value of assessing myocardial viability with DE and significant clinical implications for the selection of patients with CAD, LV dysfunction, and HF who are most likely to benefit from surgical revascularization.

Study Design

• Study Type: Interventional
• Actual Enrollment: 319 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization
• Actual Study Start Date: May 1, 2003
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medical Therapy All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.	Drug: Modern medical management; Therapies with evidence-based recommendations.; Other Names: Optimal medical therapy ; Device: Dobutamine echocardiography; Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.; Other Names: dobutamine echo ; Drug: Optimal medical therapy; All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.; Other Names: MOdern medical therapy
Active Comparator: CABG Surgical revascularization in conjunction with optimal medical therapy.	Procedure: Coronary Artery Bypass; coronary revascularization using arterial or vein conduits; Other Names: CABG ; Device: Dobutamine echocardiography; Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.; Other Names: dobutamine echo

Outcome Measures

Primary Outcome Measures

1. Survival Free of Cardiac Hospitalization [3 years]

Secondary Outcome Measures

1. Left Ventricular Ejection Fraction [4 months and 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Enrollment Requirements

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medstar Health Research Institute
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Julio Panza, Medstar Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT00074724
• Other Study ID Numbers: 153; 1R01HL070011-01A1
• First Posted: Dec 23, 2003
• Last Update Posted: Apr 8, 2021
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Dobutamine

Study Results

Participant Flow

Arm/Group Title	Medical Therapy	CABG
Arm/Group Description	All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction. Modern medical management: Therapies with evidence-based recommendations. Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium. Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.	Surgical revascularization in conjunction with optimal medical therapy. Coronary Artery Bypass: coronary revascularization using arterial or vein conduits Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Medical Therapy	CABG	Total
Arm/Group Description	All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction. Modern medical management: Therapies with evidence-based recommendations. Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium. Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.	Surgical revascularization in conjunction with optimal medical therapy. Coronary Artery Bypass: coronary revascularization using arterial or vein conduits Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Survival Free of Cardiac Hospitalization
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available

Arm/Group Title	Medical Therapy	CABG
Arm/Group Description	All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction. Modern medical management: Therapies with evidence-based recommendations. Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium. Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.	Surgical revascularization in conjunction with optimal medical therapy. Coronary Artery Bypass: coronary revascularization using arterial or vein conduits Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
Measure Participants	0	0

2. Secondary Outcome

Title	Left Ventricular Ejection Fraction
Time Frame	4 months and 2 years

Outcome Measure Data

Analysis Population Description

The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available

Arm/Group Title	Medical Therapy	CABG
Arm/Group Description	All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction. Modern medical management: Therapies with evidence-based recommendations. Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium. Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.	Surgical revascularization in conjunction with optimal medical therapy. Coronary Artery Bypass: coronary revascularization using arterial or vein conduits Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
Measure Participants	0	0

Adverse Events

Time Frame	The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available
Adverse Event Reporting Description	The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available
Arm/Group Title	Medical Therapy		CABG
Arm/Group Description	All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction. Modern medical management: Therapies with evidence-based recommendations. Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium. Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.		Surgical revascularization in conjunction with optimal medical therapy. Coronary Artery Bypass: coronary revascularization using arterial or vein conduits Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
All Cause Mortality
	Medical Therapy		CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Medical Therapy		CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Medical Therapy		CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.