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Status unknownNCT0212620280+Updated Apr 29, 2014

Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

A Phase 4 interventional study of Coronary angiography and revascularization if feasible in Non-ST Elevation Myocardial Infarction (NSTEMI) and Angina, Unstable, sponsored by Sahlgrenska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.

Sponsored by Sahlgrenska University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
80 Years and older
Sex
All
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Study summary

A multicenter, randomized clinical trial in elderly patients (over 80 years old) with unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).

A total of 200 patients will be randomized to medical treatment (100 patients) or coronary angiography with revascularization if feasible (100 patients). Information regarding prior history, frailty, clinical presentation, in-hospital events, complications, angina, quality of life and mortality will be collected. Follow up time is 1 year.

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Conditions studied

  • Non-ST Elevation Myocardial Infarction (NSTEMI)
  • Angina, Unstable

Keywords

  • Elderly
  • Octogenarians
  • PCI
  • Myocardial infarction
  • NSTEMI
  • Unstable angina pectoris
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 200 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. >80 years of age
  2. Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours.

    AND at least one of the following:

    1. ST-segment depression on ECG > 1mm
    2. Elevated cardiac troponins
  3. Written informed consent before randomization

Exclusion criteria

Exclusion criteria:

  1. Percutaneous coronary intervention (PCI) within 30 days prior to randomization
  2. Suspected ongoing active internal bleeding
  3. ST segment elevation of >1mm in two contiguous leads on ECG
  4. Enrollment in another study that has not completed the follow up phase.
  5. Known allergy to aspirin or clopidogrel
  6. Severe dementia
  7. Expected limited 1 year survival due to other disease(s)
  8. Unwillingness to participate in the trial or expected problems with compliance
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Conservative therapy

    Optimized medical therapy

  • Experimental
    Invasive therapy

    Coronary angiography and revascularization if feasible

    Procedure: Coronary angiography and revascularization if feasible

Interventions

  • ProcedureCoronary angiography and revascularization if feasible

    Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible

    Also known as: Percutaneous coronary intervention (PCI)

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What researchers measure

Primary outcomes

  1. Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke).

    Time frame: 1 year

Secondary outcomes

  1. Number of participants with major bleeding

    Time frame: 1 month

  2. Number of participants with major adverse cardiac or cerebral event

    Time frame: 1 month

  3. Number of participants with minor bleeding

    Time frame: 1 month

  4. Number of participants with composite of cardiac death or myocardial infarction

    Time frame: 1 year

  5. Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months

    Time frame: 1 year

  6. Change from baseline of participants level of angina pectoris at 12 months

    Time frame: 12 months

  7. Number of participants dead (all cause mortality)

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Department of Cardiology, Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
    Recruiting
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References and documents

Publications

  • Hirlekar G, Libungan B, Karlsson T, Back M, Herlitz J, Albertsson P. Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study. Scand Cardiovasc J. 2020 Oct;54(5):315-321. doi: 10.1080/14017431.2020.1781243. Epub 2020 Jun 26. PubMed 32586153 ↗
  • Libungan B, Hirlekar G, Albertsson P. Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:349. doi: 10.1186/1745-6215-15-349. PubMed 25189626 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02126202
Lead sponsor
Sahlgrenska University Hospital
Responsible party
Per Albertsson (Head of Cardiology, Sahlgrenska University Hospital) — Principal investigator
First posted
Apr 29, 2014
Start date
Aug 2009
Primary completion
Jan 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Apr 29, 2014

Study contacts

Per A Albertsson, MD, PhD
Contact
per.albertsson@vgregion.se
+46313421000
Per A Albertsson, PhD
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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