Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

Sahlgrenska University Hospital200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

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

Interventions

Coronary angiography and revascularization if feasiblePROCEDURE

Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiology, Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Per A Albertsson, MD, PhD

CONTACT

+46313421000 per.albertsson@vgregion.se

Data from ClinicalTrials.gov

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