After Eighty Study

Coronary Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01255540
• Other study ID #: 08/326b
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

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