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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01255540
Other study ID # 08/326b
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 6, 2010
Last updated October 21, 2015
Start date December 2010
Est. completion date February 2019

Study information

Verified date October 2015
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 492
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender Both
Age group 80 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Norway Oslo University Hospital, Rikshospitalet Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite endpoints. Does an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP improve rates of death, reinfarction, stroke and need of urgent revascularisation? One year follow up. No
Secondary Death of any cause One year from randomization No
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