Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00023595
First received: September 11, 2001
Last updated: September 25, 2013
Last verified: September 2013
  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
Other: Modern Medical Management
Procedure: Surgical Ventricular Restoration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Treatment for Ischemic Heart Failure (STICH)

Resource links provided by NLM:


Further study details as provided by Duke University:

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: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Ho1: active medical therapy alone
Other: Modern Medical Management
State-of-the-art medical therapy for coronary artery disease and heart failure management.
Experimental: 2
H01: coronary bypass surgery (CABG) intervention and Medical Therapy
Procedure: Coronary Artery Bypass
The experimental group receives medical therapy and CABG, whereas the control group receives medical therapy alone.
Other: 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
Duke University
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 Université de Montréal
Principal Investigator: Julio A Panza, MD Washington Hospital Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00023595     History of Changes
Other Study ID Numbers: Pro00018940, U01HL069012, U01 HL69009, U01 HL69010, U01 HL69011, U01 HL69012, U01 HL69013, U01 HL69015, U01 HL72683
Study First Received: September 11, 2001
Last Updated: September 25, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014