Myocardial Infarction Clinical Trial
— ABRACOSOfficial title:
Ankle-Brachial Index Estimating Cardiac Complications After Non-Cardiac Surgery
Verified date | November 2013 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Observational |
Introduction: Patients undergoing noncardiac surgery are at increased risk of cardiovascular
complications. The development of methods that can accurately predict the occurrence of
these events is of critical importance and large studies have been published with this
purpose. Based on these studies, several algorithms have been proposed to predict of
cardiovascular events postoperatively. However, quantification of this risk is often
difficult to measure, especially in those patients with subclinical disease, not always
detected in routine evaluation. The ankle brachial index (ABI) has proved a valuable tool in
the quantification of cardiovascular risk, and perhaps the most promising when compared with
other methods. It is easy, cheap, fast and feasible in office care, with a great acceptance
between patients and small intra and inter observer variability. Despite strong evidence of
the utility of ABI as a tool in assessing cardiovascular risk, there are no data about the
use of ABI in other patients referred for non vascular surgery, which constitutes the
majority of operations performed worldwide.
Objectives: To evaluate the use of ABI as a predictor of cardiovascular events in patients
undergoing non-cardiac and non-vascular surgery and its applicability as a tool in the
reclassification of patient risk groups established by guidelines for perioperative
evaluation.
Methods: 300 moderate to high risk patients referred for non-vascular and non-cardiac will
be included. Data about risk factors, signs and symptoms, physical examination and treatment
used will be collected before surgery. The ABI will be measured and the patient will be
monitored for 30 days to the detection of cardiovascular events: death from any
cardiovascular causes, unstable angina, nonfatal myocardial infarction, isolated elevation
of troponin, decompensated heart failure, cardiogenic shock, stop nonfatal heart failure,
pulmonary edema, stroke and lower limb ischemia. Postoperative electrocardiogram, total
creatine kinase, MB fraction and troponin I will be measured daily until 3º day and whenever
clinically indicated.
Status | Completed |
Enrollment | 196 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged 18 or older, moderate to high risk by Revised Cardiac Risk and the Modified Cardiac Risk Index undergoing non-cardiac and non-vascular surgery will be referred for the study. Exclusion Criteria: - Patients with atrial fibrillation, aortic regurgitation, low risk of cardiovascular complications by the Revised Cardiac Risk and the Modified Cardiac Risk Index and those referred for vascular or cardiac surgery. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Cardiovascular Events | 30 days after surgery | Yes |
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