Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes (80+)

April 27, 2014 updated by: Per Albertsson, Sahlgrenska University Hospital, Sweden

Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Department of Cardiology, Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative therapy
Optimized medical therapy
Experimental: Invasive therapy
Coronary angiography and revascularization if feasible
Procedure: Coronary angiography and revascularization if feasible
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
Other Names:
  • Percutaneous coronary intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with major bleeding
Time Frame: 1 month
1 month
Number of participants with major adverse cardiac or cerebral event
Time Frame: 1 month
1 month
Number of participants with minor bleeding
Time Frame: 1 month
1 month
Number of participants with composite of cardiac death or myocardial infarction
Time Frame: 1 year
1 year
Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months
Time Frame: 1 year
1 year
Change from baseline of participants level of angina pectoris at 12 months
Time Frame: 12 months
12 months
Number of participants dead (all cause mortality)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Per A Albertsson, PhD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

April 27, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80+

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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