After Eighty Study

NCT01255540 | Unknown DMC

• 1 other identifier: 08/326b
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Coronary heart disease in patients over; 80 years of age.

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Death of any cause

  One year from randomization

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multicenter study

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Location

Related Publications (4)

• Berg ES, Tegn NK, Abdelnoor M, Roysland K, Ryalen PC, Aaberge L, Eek C, Oie E, Juliebo V, Gjertsen E, Ranhoff AH, Gullestad L, Nordstrand N, Bendz B; After Eighty Study Investigators. Long-Term Outcomes of Invasive vs Conservative Strategies for Older Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2023 Nov 21;82(21):2021-2030. doi: 10.1016/j.jacc.2023.09.809.

  PMID: 37968019 DERIVED

• Tegn N, Eek C, Abdelnoor M, Aaberge L, Endresen K, Skardal R, Berg ES, Gullestad L, Bendz B. Patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris randomised to an invasive versus conservative strategy: angiographic and procedural results from the After Eighty study. Open Heart. 2020 Jul;7(2):e001256. doi: 10.1136/openhrt-2020-001256.

  PMID: 32719073 DERIVED

• Tegn N, Abdelnoor M, Aaberge L, Hylen Ranhoff A, Endresen K, Gjertsen E, Skardal R, Gullestad L, Bendz B; After Eighty study investigators. Health-related quality of life in older patients with acute coronary syndrome randomised to an invasive or conservative strategy. The After Eighty randomised controlled trial. Age Ageing. 2018 Jan 1;47(1):42-47. doi: 10.1093/ageing/afx121.

  PMID: 28985265 DERIVED

• Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.

  PMID: 26794722 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bjørn Bendz MD PhD

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

NO (1)