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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Coronary angiography and revascularization if feasible
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST Elevation Myocardial Infarction (NSTEMI) focused on measuring Elderly, Octogenarians, PCI, Myocardial infarction, NSTEMI, Unstable angina pectoris

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conservative therapy

Invasive therapy

Arm Description

Optimized medical therapy

Coronary angiography and revascularization if feasible

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2014
Last Updated
April 27, 2014
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02126202
Brief Title
Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes
Acronym
80+
Official Title
Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Elevation Myocardial Infarction (NSTEMI), Angina, Unstable
Keywords
Elderly, Octogenarians, PCI, Myocardial infarction, NSTEMI, Unstable angina pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative therapy
Arm Type
No Intervention
Arm Description
Optimized medical therapy
Arm Title
Invasive therapy
Arm Type
Experimental
Arm Description
Coronary angiography and revascularization if feasible
Intervention Type
Procedure
Intervention Name(s)
Coronary angiography and revascularization if feasible
Other Intervention Name(s)
Percutaneous coronary intervention (PCI)
Intervention Description
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number of participants with major bleeding
Time Frame
1 month
Title
Number of participants with major adverse cardiac or cerebral event
Time Frame
1 month
Title
Number of participants with minor bleeding
Time Frame
1 month
Title
Number of participants with composite of cardiac death or myocardial infarction
Time Frame
1 year
Title
Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months
Time Frame
1 year
Title
Change from baseline of participants level of angina pectoris at 12 months
Time Frame
12 months
Title
Number of participants dead (all cause mortality)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >80 years of age 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: ST-segment depression on ECG > 1mm Elevated cardiac troponins Written informed consent before randomization Exclusion criteria: Percutaneous coronary intervention (PCI) within 30 days prior to randomization Suspected ongoing active internal bleeding ST segment elevation of >1mm in two contiguous leads on ECG Enrollment in another study that has not completed the follow up phase. Known allergy to aspirin or clopidogrel Severe dementia Expected limited 1 year survival due to other disease(s) Unwillingness to participate in the trial or expected problems with compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per A Albertsson, MD, PhD
Phone
+46313421000
Email
per.albertsson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per A Albertsson, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berglind Libungan, MD
Phone
+46313421000
Email
berglind.libungan@vgregion.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
32586153
Citation
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.
Results Reference
derived
PubMed Identifier
25189626
Citation
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.
Results Reference
derived

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Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

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