80+: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02126202
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 77
• Patients Per Site Per Month: 2.6

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study
• Study Start Date: Aug 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2015
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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). [1 year]

Secondary Outcome Measures

1. Number of participants with major bleeding [1 month]

2. Number of participants with major adverse cardiac or cerebral event [1 month]

3. Number of participants with minor bleeding [1 month]

4. Number of participants with composite of cardiac death or myocardial infarction [1 year]

5. Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months [1 year]

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

7. Number of participants dead (all cause mortality) [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 80 Years and Older
• Sexes Eligible for Study: 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:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, Sahlgrenska University Hospital	Gothenburg		Sweden	41345

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Albertsson, Head of Cardiology, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT02126202
• Other Study ID Numbers: 80+
• First Posted: Apr 29, 2014
• Last Update Posted: Apr 29, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Per Albertsson, Head of Cardiology, Sahlgrenska University Hospital, Sweden: Elderly; Octogenarians; PCI; Myocardial infarction; NSTEMI; Unstable angina pectoris
• Additional relevant MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable; Infarction

Study Results

No Results Posted as of Apr 29, 2014