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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014