Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00023595

Purpose

This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular restoration for patients with congestive heart failure and coronary artery disease (CAD).

Condition	Intervention	Phase
Cardiovascular Diseases Coronary Disease Heart Failure, Congestive Heart Diseases	Procedure: Coronary Artery Bypass Drug: Modern Medical Management Procedure: Surgical Ventricular Restoration	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Surgical Treatment for Ischemic Heart Failure (STICH)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Heart Diseases Heart Failure Surgery

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

H01-Total mortality; H02-Long-term survival free of cardiac hospitalization [ Time Frame: H02 will be providing results in 2009; H01 results are anticipated in 2011-2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cost-effectiveness [ Time Frame: H02: 2010; H01:2012 ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: H02:2010; H01: 2012 ] [ Designated as safety issue: No ]
Exercise capacity [ Time Frame: H01: 2012; H02: 2010 ] [ Designated as safety issue: No ]
Treatment-specific prediction of primary endpoints by baseline measurements of myocardial ischemia and viability and by baseline and post-treatment measurements of LV size and function, and neurohormonal and pro-inflammatory cytokine levels [ Time Frame: H01: 2012-3, H02: 2010-11 ] [ Designated as safety issue: No ]

Enrollment:	2136
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Ho1: active medical therapy alone	Drug: Modern Medical Management State-of-the-art medical therapy for coronary artery disease and heart failure management.
2: Experimental H01: coronary bypass surgery (CABG) intervention	Procedure: Coronary Artery Bypass The experimental group receives medical therapy and CABG, whereas the control group receives medical therapy alone. Drug: Modern Medical Management State-of-the-art medical therapy for coronary artery disease and heart failure management. Procedure: Surgical Ventricular Restoration H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for Ho1: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

Arms

Assigned Interventions

1: No Intervention

Ho1: active medical therapy alone

Drug: Modern Medical Management

State-of-the-art medical therapy for coronary artery disease and heart failure management.

2: Experimental

H01: coronary bypass surgery (CABG) intervention

Procedure: Coronary Artery Bypass

The experimental group receives medical therapy and CABG, whereas the control group receives medical therapy alone.

Drug: Modern Medical Management

State-of-the-art medical therapy for coronary artery disease and heart failure management.

Procedure: Surgical Ventricular Restoration

H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for Ho1: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptomatic heart failure defined as New York Heart Association (NYHA) Class II-IV (within 3 months of entry)
LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
Coronary anatomy suitable for revascularization

Exclusion Criteria:

Clearly defined primary valvular heart disease indicating the need for valve repair or replacement
Concurrent cardiogenic shock, or requiring inotropic or intra-aortic balloon support
Percutaneous coronary intervention (PCI) planned for CAD treatment
Acute myocardial infarction within 30 days of study entry
More than one prior cardiac operation
Non-cardiac illness with life expectancy less than 3 years
Non-cardiac illness imposing substantial operative mortality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023595

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27715

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Robert Bonow	Radionuclide Core Lab, Northwestern University
Principal Investigator:	Arthur Feldman	Neurohormonal Core Lab, Jefferson University
Principal Investigator:	Robert Jones	Clinical Coordinating Center, Duke University
Principal Investigator:	Kerry Lee	Data Coordinating Center, Duke University
Principal Investigator:	Daniel Mark	Economics and Quality of Life Core Lab, Duke University
Principal Investigator:	Jae Oh	Echocardiographic Core Lab, Mayo Clinic
Principal Investigator:	Gerald Pohost	Magnetic Resonance Imaging Core Lab, University of Southern California
Study Chair:	Jean Rouleau	University of Montreal
Principal Investigator:	Julio A Panza, MD	Washington Hospital Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Mark DB, Knight JD, Velazquez EJ, Howlett JG, Spertus JA, Djokovic LT, Harding TM, Rankin GR, Drew LA, Szygula-Jurkiewicz B, Adlbrecht C, Anstrom KJ; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J. 2009 May;157(5):837-44, 844.e1-3. Epub 2009 Apr 1.

Jones RH, Velazquez EJ, Michler RE, Sopko G, Oh JK, O'Connor CM, Hill JA, Menicanti L, Sadowski Z, Desvigne-Nickens P, Rouleau JL, Lee KL; STICH Hypothesis 2 Investigators. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. 2009 Apr 23;360(17):1705-17. Epub 2009 Mar 29.

Responsible Party:	NHLBI, DCVD ( Patrice Desvigne-Nickens, MD, Program Director )
Study ID Numbers:	140, U01 HL69009, U01 HL69010, U01 HL69011, U01 HL69012, U01 HL69013, U01 HL69015, U01 HL72683
Study First Received:	September 11, 2001
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00023595 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Failure
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010