After Eighty Study

NCT ID: NCT01255540

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 492 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2019-02-28

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Oslo University Hospital

Bjørn Bendz MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37968019 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32719073 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28985265 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26794722 (View on PubMed)

Other Identifiers

08/326b

Identifier Type: -

Identifier Source: org_study_id