Coronary Heart DiseaseNCT01255540
After Eighty Study
An observational study of Coronary Heart Disease, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 492 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2010to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Multicenter study
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: One year follow up.
Secondary outcomes (1)
Death of any cause
Measured: One year from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oslo University Hospital, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255540
- Sponsor's protocol ID
- 08/326b
- Status last verified
- Oct 2015
- First submitted
- 6 Dec 2010
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37968019Tegn 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.
PubMed 32719073Tegn 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.
PubMed 28985265Tegn 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.
PubMed 26794722
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01255540
- Acronym / sponsor ID
- 08/326b
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease in patients over, 80 years of age.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Multicenter study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?
1 secondary outcome
Death of any cause
Time frame: One year from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 37968019Berg 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.
- Derived from this study: PubMed 32719073Tegn 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.
- Derived from this study: PubMed 28985265Tegn 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.
- Derived from this study: PubMed 26794722Tegn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoints. (time frame: One year follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.