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After Eighty Study

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ClinicalTrials.gov Identifier: NCT01255540
Recruitment Status : Active, not recruiting
First Posted : December 7, 2010
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Coronary Heart Disease

Study Design

Study Type : Observational
Estimated Enrollment : 492 participants
Observational Model: Case Control
Time Perspective: Prospective
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)
Study Start Date : December 2010
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Composite endpoints. [ Time Frame: One year follow up. ]
    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?


Secondary Outcome Measures :
  1. Death of any cause [ Time Frame: One year from randomization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multicenter study
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255540


Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital, Bjørn Bendz MD PhD
ClinicalTrials.gov Identifier: NCT01255540     History of Changes
Other Study ID Numbers: 08/326b
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Oslo University Hospital:
Coronary heart disease in patients over
80 years of age.

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Non-ST Elevated Myocardial Infarction
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Myocardial Infarction