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Trial · NCT01020968

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding)
Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryLeft ventricular ejection fraction (LVEF) (As determined by Echo, Cardiac CT and SPECT)Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
SecondaryChange in LV and RV dimensions and in LV volumes (As determined by Echo, Cardiac CT and SPECT)Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
SecondaryWall Motion Score Index (WMSI) (As determined by Echo, Cardiac CT and SPECT)Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
SecondaryAssessment of myocardial perfusion in ischemic patient cohort, only (As determined by SPECT)Baseline and Month 3
SecondaryExercise tolerance (6 minute walk test)Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryHeart failure status (As determined by New York Heart Association (NYHA) heart failure status (NYHA) class and Brain Natriuretic Peptide [BNP])Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryAngina status (As determined by Canadian Cardiovascular Society (CCS) classification and Troponin I Levels)Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryQuality of life (As determined by Minnesota Living with Heart Failure Questionnaire [MLHFQ])Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryPulmonary function (As determined by metabolic stress test)Baseline, Month 6 and Month 12
SecondaryDevice implantation, transplantation and positive inotrope use (As determined by incidence rates)Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryAICD firing rateOutcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
SecondaryChanges in medication for heart failureOutcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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