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After Eighty Study

This study is currently recruiting participants.
Verified May 2012 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01255540
First received: December 6, 2010
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Coronary Heart Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Composite endpoints. [ Time Frame: One year follow up. ] [ Designated as safety issue: No ]
    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:
  • Death of any cause [ Time Frame: One year from randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 492
Study Start Date: September 2010
  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255540

Contacts
Contact: Bjørn Bendz, MD PhD (chairman) +47-95802582 Bjorn.Bendz@oslo-universitetssykehus.no
Contact: Nicolai K. Tegn, PhD student +47-98696554 n.k.tegn@gmail.com

Locations
Norway
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway
Contact: Bjørn Bendz, PhD     +4795802582     Bjorn.Bendz@oslo-universitetssykehus.no    
Contact: Nicolai K. Tegn, PhD student     +4798696554     n.k.tegn@gmail.com    
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Bjørn Bendz, Rikshospitalet, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01255540     History of Changes
Other Study ID Numbers: 08/326b
Study First Received: December 6, 2010
Last Updated: May 9, 2012
Health Authority: Regional Ethics Commitee:Norway

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

Additional relevant MeSH terms:
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Myocardial Infarction
Angina Pectoris
 Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 22, 2013