Ankle-Brachial Index Estimating Cardiac Complications After Surgery (ABRACOS)

November 9, 2013 updated by: Bruno Caramelli, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both sex patients aged 18 or older, undergoing non-cardiac and non-vascular surgery will be referred for the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ankle Brachial Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Cardiovascular Events
Time Frame: 30 days after surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Bruno Caramelli, Ph.D., Heart Institute - University of São Paulo
  • Principal Investigator: Gabriel A Carmo, M.D., Heart Institute - University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 8, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 9, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP - 0175/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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