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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00023595
First received: September 11, 2001
Last updated: July 20, 2017
Last verified: July 2017
Results First Received: December 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Failure, Congestive
Heart Diseases
Interventions: Procedure: CABG surgery plus MED
Drug: Active Medication Alone
Procedure: CABG plus MED and SVR

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pts were assigned to 1 of 3 strata before randomization. All pts in stratum C and some pts in stratum B were randomly assigned to med therapy + CABG or med therapy + CABG + SVR (Hypothesis 2 component of the trial-HO2). 76 of stratum B pts who were randomized to med therapy + CABG group belong to both H01 and H02.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Stratum A: eligible for med. therapy alone or med therapy + CABG; Stratum C: eligible for med therapy + CABG or med therapy + CABG + SVR; Stratum B: eligible for all 3 treatment options. All pts in stratum A and some of the pts in stratum B were randomized to either med therapy alone or med therapy + CABG (Hypothesis 1 of the STICH trial--H01).

Reporting Groups
  Description
H01: Medication 50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
H01: Medication + CABG 50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
H01+H02: Medication + CABG This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
H02: Medication+CABG 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
H02: Medication+CABG+SVR 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Participant Flow for 2 periods

Period 1:   5 Year Follow up
    H01: Medication   H01: Medication + CABG   H01+H02: Medication + CABG   H02: Medication+CABG   H02: Medication+CABG+SVR
STARTED   602   534   76   423 [1]   501 
COMPLETED   600   532   75   416   498 
NOT COMPLETED   2   2   1   7   3 
Lost to Follow-up                2                2                1                7                3 
[1] 76 of stratum B pts who were randomized to med therapy + CABG group belong to both H01 and H02.

Period 2:   10 Year Follow up
    H01: Medication   H01: Medication + CABG   H01+H02: Medication + CABG   H02: Medication+CABG   H02: Medication+CABG+SVR
STARTED   602 [1]   534 [1]   76 [1]   0 [2]   0 [2] 
COMPLETED   590   524   73   0 [2]   0 [2] 
NOT COMPLETED   12   10   3   0   0 
Lost to Follow-up                12                10                3                0                0 
[1] all participants who started H01 were counted as starting the 10 year follow up.
[2] H02 arm was not extended and ended at year 5



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
H01: Medication 50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
H01: Medication + CABG 50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
H01+H02: Medication + CABG This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
H02: Medication+CABG 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
H02: Medication+CABG+SVR 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
Total Total of all reporting groups

Baseline Measures
   H01: Medication   H01: Medication + CABG   H01+H02: Medication + CABG   H02: Medication+CABG   H02: Medication+CABG+SVR   Total 
Overall Participants Analyzed 
[Units: Participants]
 602   534   76   423   501   2136 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 59 
 (53 to 67) 
 60 
 (54 to 68) 
 61 
 (54 to 68) 
 62 
 (55 to 69) 
 62 
 (55 to 69) 
 60 
 (54 to 68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      75  12.5%      64  12.0%      9  11.8%      69  16.3%      69  13.8%      286  13.4% 
Male      527  87.5%      470  88.0%      67  88.2%      354  83.7%      432  86.2%      1850  86.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   H01: All Cause Mortality   [ Time Frame: 5 years post randomization ]

2.  Primary:   H01: All Cause Mortality   [ Time Frame: 10 years post randomization ]

3.  Primary:   H02: All-cause Mortality or Cardiovascular Hospitalization   [ Time Frame: 5 years post randomization ]

4.  Secondary:   H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).   [ Time Frame: 10 years post randomization ]

5.  Secondary:   H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).   [ Time Frame: 5 years post randomization ]

6.  Secondary:   H01: Mortality or Cardiovascular Hospitalization   [ Time Frame: up to 5 years post randomization ]

7.  Secondary:   H01: Mortality or Cardiovascular Hospitalization   [ Time Frame: up to 10 years post randomization ]

8.  Secondary:   H02: All-cause Mortality   [ Time Frame: up to 5 years ]

9.  Secondary:   H01: All-cause Mortality Within 30 Days After Randomization   [ Time Frame: 30 days post randomization ]

10.  Secondary:   H02: All-cause Mortality Within 30 Days After Randomization   [ Time Frame: 30 days post randomization ]

11.  Secondary:   H01: All-cause Mortality or Heart-failure Hospitalization   [ Time Frame: 5 years post randomization ]

12.  Secondary:   H02: All-cause Mortality or Heart-failure Hospitalization   [ Time Frame: 5 years post randomization ]

13.  Secondary:   H01: All-cause Mortality or Heart-failure Hospitalization   [ Time Frame: 10 years post randomization ]

14.  Secondary:   H01: Heart Failure Hospitalization   [ Time Frame: 5 years post randomization ]

15.  Secondary:   H02: Heart Failure Hospitalization   [ Time Frame: 5 years post randomization ]

16.  Secondary:   H01: Heart Failure Hospitalization   [ Time Frame: 10 years post randomization ]

17.  Secondary:   H01: Cardiac Procedure: Heart Transplant   [ Time Frame: 5 years post randomization ]

18.  Secondary:   H02: Cardiac Procedure: Heart Transplant   [ Time Frame: 5 years post randomization ]

19.  Secondary:   H01: Cardiac Procedure: Heart Transplant   [ Time Frame: 10 years post randomization ]

20.  Secondary:   H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)   [ Time Frame: 5 years post randomization ]

21.  Secondary:   H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)   [ Time Frame: 5 years post randomization ]

22.  Secondary:   H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)   [ Time Frame: 10 years post randomization ]

23.  Secondary:   H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)   [ Time Frame: 5 years post randomization ]

24.  Secondary:   H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)   [ Time Frame: 5 years post randomization ]

25.  Secondary:   H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)   [ Time Frame: 10 years post randomization ]

26.  Secondary:   H01: Stroke   [ Time Frame: 5 years post randomization ]

27.  Secondary:   H01: Stroke   [ Time Frame: 10 years post randomization ]

28.  Secondary:   H02: Stroke   [ Time Frame: 5 years post randomization ]

29.  Secondary:   H01: All-cause Mortality or Revascularization (CABG or PCI)   [ Time Frame: 5 years post randomization ]

30.  Secondary:   H02: All-cause Mortality or Revascularization (CABG or PCI)   [ Time Frame: 5 years post randomization ]

31.  Secondary:   H01: All-cause Mortality or Revascularization (CABG or PCI)   [ Time Frame: 10 years post randomization ]

32.  Secondary:   H01: All-cause Mortality, Heart Transplant or LVAD   [ Time Frame: 5 years post randomization ]

33.  Secondary:   H02: All-cause Mortality, Heart Transplant or LVAD   [ Time Frame: 5 years post randomization ]

34.  Secondary:   H01: All-cause Mortality, Heart Transplant or LVAD   [ Time Frame: 10 years post randomization ]

35.  Secondary:   H01: All-cause (Unplanned and Elective) Hospitalization   [ Time Frame: 5 years post randomization ]

36.  Secondary:   H02: All-cause (Unplanned and Elective) Hospitalization   [ Time Frame: 5 years post randomization ]

37.  Secondary:   H01: All-cause (Unplanned and Elective) Hospitalization   [ Time Frame: 10 years post randomization ]

38.  Secondary:   H01: 6 Minute Walk Distance   [ Time Frame: From randomization to 24 month follow-up ]

39.  Secondary:   H02: 6 Minute Walk Distance   [ Time Frame: From randomization to 24 month follow-up ]

40.  Secondary:   H01: Exercise Duration   [ Time Frame: From randomization to 24 months follow-up ]

41.  Secondary:   H02: Exercise Duration   [ Time Frame: From randomization to 24 months follow-up ]

42.  Secondary:   H01: LVEF by ECHO Core Lab During Follow-up   [ Time Frame: From randomization to 24 months follow-up ]

43.  Secondary:   H02: LVEF by ECHO Core Lab During Follow-up   [ Time Frame: From randomization to 24 months follow-up ]

44.  Secondary:   H01: LVEF by RN Core Lab During Follow-up   [ Time Frame: From randomization to 24 months follow-up ]

45.  Secondary:   H02: LVEF by RN Core Lab During Follow-up   [ Time Frame: From randomization to 24 months follow-up ]

46.  Secondary:   H01: LVEF by CMR Core Lab During Follow-up   [ Time Frame: From randomization to 24 months follow-up ]

47.  Secondary:   H02: LVEF by CMR Core Lab During Follow-up   [ Time Frame: From randomization to 24 months follow-up ]

48.  Secondary:   H01: B-type Natriuretic Peptide (BNP)   [ Time Frame: From randomization to 24 months follow-up ]

49.  Secondary:   H02: B-type Natriuretic Peptide (BNP)   [ Time Frame: From randomization to 24 months follow-up ]

50.  Secondary:   H01: SF-36 Mental Health Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

51.  Secondary:   H02: SF-36 Mental Health Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

52.  Secondary:   H01:SF-36 Role Physical Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

53.  Secondary:   H02: SF-36 Role Physical Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

54.  Secondary:   H01:SF-36 Role Emotional Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

55.  Secondary:   H02: SF-36 Role Emotional Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

56.  Secondary:   H01:SF-36 Social Functioning Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

57.  Secondary:   H02: SF-36 Social Functioning Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

58.  Secondary:   H01:SF-36 Vitality Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

59.  Secondary:   H02: SF-36 Vitality Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

60.  Secondary:   H01:SF-12 Physical Component Summary (PCS) Scale   [ Time Frame: From enrollment to 3-year follow-up ]

61.  Secondary:   H02: SF-12 Physical Component Summary (PCS) Scale   [ Time Frame: From enrollment to 3-year follow-up ]

62.  Secondary:   H01: SF-12 Mental Component Summary (MCS) Scale   [ Time Frame: From enrollment to 3-year follow-up ]

63.  Secondary:   H02: SF-12 Mental Component Summary (MCS) Scale   [ Time Frame: From enrollment to 3-year follow-up ]

64.  Secondary:   H01: KCCQ Physical Limitation Scale   [ Time Frame: From enrollment to 3-year follow-up ]

65.  Secondary:   H02: KCCQ Physical Limitation Scale   [ Time Frame: From enrollment to 3-year follow-up ]

66.  Secondary:   H01: KCCQ Symptom Stability   [ Time Frame: From enrollment to 3-year follow-up ]

67.  Secondary:   H02: KCCQ Symptom Stability   [ Time Frame: From enrollment to 3-year follow-up ]

68.  Secondary:   H01: KCCQ Symptom Frequency   [ Time Frame: From enrollment to 3-year follow-up ]

69.  Secondary:   H02: KCCQ Symptom Frequency   [ Time Frame: From enrollment to 3-year follow-up ]

70.  Secondary:   H01: KCCQ Symptom Burden   [ Time Frame: From enrollment to 3-year follow-up ]

71.  Secondary:   H02: KCCQ Symptom Burden   [ Time Frame: From enrollment to 3-year follow-up ]

72.  Secondary:   H01: KCCQ Total Symptoms   [ Time Frame: From enrollment to 3-year follow-up ]

73.  Secondary:   H02: KCCQ Total Symptoms   [ Time Frame: From enrollment to 3-year follow-up ]

74.  Secondary:   H01: KCCQ Quality-of-Life Scale   [ Time Frame: From enrollment to 3-year follow-up ]

75.  Secondary:   H02: KCCQ Quality-of-Life Scale   [ Time Frame: From enrollment to 3-year follow-up ]

76.  Secondary:   H01: KCCQ Social Limitation   [ Time Frame: From enrollment to 3-year follow-up ]

77.  Secondary:   H02: KCCQ Social Limitation   [ Time Frame: From enrollment to 3-year follow-up ]

78.  Secondary:   H01: KCCQ Clinical Summary Score   [ Time Frame: From enrollment to 3-year follow-up ]

79.  Secondary:   H02: KCCQ Clinical Summary Score   [ Time Frame: From enrollment to 3-year follow-up ]

80.  Secondary:   H01: KCCQ Overall Summary Score   [ Time Frame: From enrollment to 3-year follow-up ]

81.  Secondary:   H02: KCCQ Overall Summary Score   [ Time Frame: From enrollment to 3-year follow-up ]

82.  Secondary:   H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

83.  Secondary:   H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

84.  Secondary:   H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

85.  Secondary:   H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

86.  Secondary:   H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

87.  Secondary:   H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

88.  Secondary:   H01: EQ-5D Visual Analog Scale   [ Time Frame: From enrollment to 3-year follow-up ]

89.  Secondary:   H02: EQ-5D Visual Analog Scale   [ Time Frame: From enrollment to 3-year follow-up ]

90.  Secondary:   H01: EQ-5D Health Status Index Score   [ Time Frame: From enrollment to 3-year follow-up ]

91.  Secondary:   H02: EQ-5D Health Status Index Score   [ Time Frame: From enrollment to 3-year follow-up ]

92.  Secondary:   H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale   [ Time Frame: From enrollment to 3-year follow-up ]

93.  Secondary:   H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale   [ Time Frame: From enrollment to 3-year follow-up ]

94.  Secondary:   H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

95.  Secondary:   H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

96.  Secondary:   H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

97.  Secondary:   H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale   [ Time Frame: From enrollment to 3-year follow-up ]

98.  Secondary:   H01: General Health Rating Scale   [ Time Frame: From enrollment to 3-year follow-up ]

99.  Secondary:   H02: General Health Rating Scale   [ Time Frame: From enrollment to 3-year follow-up ]

100.  Secondary:   H01: Cost of Care   [ Time Frame: index hospital admission ]

101.  Secondary:   H02: Cost of Care   [ Time Frame: index hospital admission ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Eric Velazquez
Organization: Duke University Health System
phone: 919-668-8700
e-mail: velaz002@mc.duke.edu


Publications:
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
U01HL069009 ( U.S. NIH Grant/Contract )
U01HL069010 ( U.S. NIH Grant/Contract )
U01HL069011 ( U.S. NIH Grant/Contract )
U01HL069012 ( U.S. NIH Grant/Contract )
U01HL069013 ( U.S. NIH Grant/Contract )
U01HL069015 ( U.S. NIH Grant/Contract )
U01HL072683 ( U.S. NIH Grant/Contract )
R01HL105853 ( U.S. NIH Grant/Contract )
Pro00010463 ( Other Identifier: Duke IRB )
Study First Received: September 11, 2001
Results First Received: December 23, 2016
Last Updated: July 20, 2017