Ankle-Brachial Index Estimating Cardiac Complications After Surgery

Myocardial Infarction Clinical Trial

— ABRACOS  

Official title:

Ankle-Brachial Index Estimating Cardiac Complications After Non-Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452282
• Other study ID #: USP - 0175/11
• Status: Completed
• Phase: N/A
• First received: October 8, 2011
• Last updated: November 9, 2013
• Start date: October 2011
• Est. completion date: November 2013

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Cardiovascular Complications
• Myocardial Infarction

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Cardiovascular Events		30 days after surgery	Yes