Clinical Trial: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with major bleeding [ Time Frame: 1 month ]
  • Number of participants with major adverse cardiac or cerebral event [ Time Frame: 1 month ]
  • Number of participants with minor bleeding [ Time Frame: 1 month ]
  • Number of participants with composite of cardiac death or myocardial infarction [ Time Frame: 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 ]
  • Change from baseline of participants level of angina pectoris at 12 months [ Time Frame: 12 months ]
  • Number of participants dead (all cause mortality) [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: January 7, 2014
Date Started: August 2009
Date Completion: January 2016
Last Updated: April 27, 2014
Last Verified: January 2014