This trial is active, not recruiting.

Condition coronary heart disease
Sponsor Oslo University Hospital
Start date December 2010
End date February 2019
Trial size 492 participants
Trial identifier NCT01255540, 08/326b


The rationale of the present clinical trial is to study whether an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death, reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of life. The invasive approach involves coronary angiography with immediate evaluation for three different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are commonly treated less vigorously than younger patients and the present guidelines are based on a considerably younger population.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Composite endpoints.
time frame: One year follow up.

Secondary Outcomes

Death of any cause
time frame: One year from randomization

Eligibility Criteria

Male or female participants at least 80 years old.

Inclusion Criteria: - Age ≥ 80 years. - Acute coronary syndrome (NSTEMI/UAP) with chest pain > 10 minutes, with or without ST-segment depression in ECG, and normal or elevated levels of troponin T or I. Elevated troponin levels are defined as values exceeding the 99 percentile of a normal population at the local laboratory at each participating site. - Clinical stable Exclusion Criteria: - Age < 80 years. - ST-segment elevation in ECG (STEMI) - Clinical unstable with ongoing chest pain or other ischaemic symptoms/signs. - Cardiogenic shock. - Short life expectancy due to extra cardiac reason, ie. COPD, disseminated malignant disease, or other reason. - Anamnestic indications for significant mental disorder, including dementia. - Any condition which interferes with patients possibility to comply with protocol.

Additional Information

Official title A Randomised Prospective Study of an Invasive Strategy Versus Medical Therapy in Patients Over 80 Years With Non ST-Elevation Myocardial Infarction (NSTEMI) or Unstable Angina Pectoris (UAP)
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Oslo University Hospital.