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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: October 13, 2014
Last verified: October 2014
  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: CABG surgery plus MED
Drug: Active Medication Alone
Procedure: CABG plus MED and SVR
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
Active Comparator: Active Medication Alone (MED)
Medical therapy alone to treat Coronary Artery Disease
Drug: Active Medication Alone
Standard medication for coronary artery disease and heart failure management.
Other Name: Standard medications for managment of CAD and heart failure
Active Comparator: CABG surgery plus MED
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
Procedure: CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
Drug: Active Medication Alone
Standard medication for coronary artery disease and heart failure management.
Other Name: Standard medications for managment of CAD and heart failure
Active Comparator: CABG plus MED and SVR
CABG plus Medication and Surgical ventricular reconstruction (SVR)
Procedure: CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
Drug: Active Medication Alone
Standard medication for coronary artery disease and heart failure management.
Other Name: Standard medications for managment of CAD and heart failure
Procedure: CABG plus MED and SVR
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 H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

  Show Detailed Description

  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, U01HL069009, U01HL069010, U01HL069011, U01HL069013, U01HL069015, U01HL072683
Study First Received: September 11, 2001
Last Updated: October 13, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 19, 2014