Angina, Unstable, Non-ST Elevation Myocardial Infarction (NSTEMI)
Conditions
Keywords
Elderly, Octogenarians, PCI, Myocardial infarction, NSTEMI, Unstable angina pectoris
Brief summary
A multicenter, randomized clinical trial in elderly patients (over 80 years old) with unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI). A total of 200 patients will be randomized to medical treatment (100 patients) or coronary angiography with revascularization if feasible (100 patients). Information regarding prior history, frailty, clinical presentation, in-hospital events, complications, angina, quality of life and mortality will be collected. Follow up time is 1 year.
Interventions
PROCEDURECoronary angiography and revascularization if feasible
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>80 years of age 2. Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours. AND at least one of the following: 1. ST-segment depression on ECG \> 1mm 2. Elevated cardiac troponins 3. Written informed consent before randomization
Exclusion criteria
1. Percutaneous coronary intervention (PCI) within 30 days prior to randomization 2. Suspected ongoing active internal bleeding 3. ST segment elevation of \>1mm in two contiguous leads on ECG 4. Enrollment in another study that has not completed the follow up phase. 5. Known allergy to aspirin or clopidogrel 6. Severe dementia 7. Expected limited 1 year survival due to other disease(s) 8. Unwillingness to participate in the trial or expected problems with compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke). | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with major adverse cardiac or cerebral event | 1 month |
| Number of participants with minor bleeding | 1 month |
| Number of participants with composite of cardiac death or myocardial infarction | 1 year |
| Number of participants with major bleeding | 1 month |
| Change from baseline of participants level of angina pectoris at 12 months | 12 months |
| Number of participants dead (all cause mortality) | 1 year |
| Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months | 1 year |
Countries
Sweden
Contacts
Primary ContactPer A Albertsson, MD, PhD
Outcome results
None listed