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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Sahlgrenska University Hospital, Sweden
Sponsor:
Information provided by (Responsible Party):
Per Albertsson, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT02126202
First received: January 7, 2014
Last updated: April 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Non-ST Elevation Myocardial Infarction (NSTEMI)
Angina, Unstable
Procedure: Coronary angiography and revascularization if feasible
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

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). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with major bleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Number of participants with major adverse cardiac or cerebral event [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of participants with minor bleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Number of participants with composite of cardiac death or myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change from baseline of participants level of angina pectoris at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of participants dead (all cause mortality) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Percutaneous coronary intervention (PCI)

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126202

Contacts
Contact: Per A Albertsson, MD, PhD +46313421000 per.albertsson@vgregion.se

Locations
Sweden
Department of Cardiology, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Berglind Libungan, MD    +46313421000    berglind.libungan@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Per A Albertsson, PhD Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Per Albertsson, Head of Cardiology, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02126202     History of Changes
Other Study ID Numbers: 80+
Study First Received: January 7, 2014
Last Updated: April 27, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Elderly
Octogenarians
PCI
Myocardial infarction
NSTEMI
Unstable angina pectoris

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 21, 2014