diabetes Heart attack reduced heart function
Conditions
Interventions
Approximately 2/3 of study participants (about 1200 out of 1800) will receive
the S-ICD and 1/3 of study participants (about 600 of 1800) will continue their
current medical care without an S-ICD.
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age * 65 years on date of consent * Diabetes mellitus treated with oral hypoglycemic agents, non-insulin injectable and/or insulin for the past 3calendar months or longer prior to consent date * LV ejection fraction (LVEF) of 36-50% documented by imaging (preferably by MRI or echocardiographic methods), within 12 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG * One or more clinically documented, enzyme-positive myocardial infarctions, more than 3 calendar months prior to consent date*. o If enzyme information and clinical documentation is not available, there must be a clear evidence of prior silent myocardial infarction identified as either new pathologic Q waves on ECG or imaging documentation of an infarcted area (left ventricular angiography/ nuclear scan/ MRI)* * MI qualification based on the Universal Definition of MI1 * Qualifying 12-lead ECG within 6 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG * The qualifying ECG can be sinus rhythm or atrial fibrillation (patients with persistent or permanent atrial fibrillation should have a controlled ventricular response 90 msec * Passing S-ICD Screening ECG performed per applicable user*s manual on or after the consent date that identifies one or more qualifying S-ICD sensing vectors
Exclusion criteria
Exclusion criteria: * Ejection fraction >50% or 45 kg/m2 * On a heart transplant list or likely to undergo heart transplant within one calendar year * Presence of any other disease, other than the subject*s cardiac disease, that in the opinion of the investigator is likely to significantly reduce the patient*s likelihood of survival for the duration of the trial (e.g. cancer, liver failure). * Unwillingness or inability to cooperate with the protocol * Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult * Reversible causes of heart disease (e.g. viral myocarditis or tachycardia induced cardiomyopathy) * Participation in other clinical trials (observational registries are allowed with approval from the CDC) * Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial * Unwillingness to sign the consent for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is all-cause mortality. The primary objective is to test the hypothesis that post-MI diabetic patients with relatively preserved ejection fraction of 36-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator (S-ICD). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to evaluate the effects of the S-ICD on all-cause mortality in various subgroups and on sudden cardiac death. | — |
Countries
Netherlands
Outcome results
None listed