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Ankle-Brachial Index Estimating Cardiac Complications After Surgery

NCT ID: NCT01452282

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Complications Myocardial Infarction Acute Coronary Syndromes

Keywords

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Ankle Brachial Index Perioperative care General Surgery Acute Coronary Syndromes Cardiovascular Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ankle Brachial Index

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Caramelli

Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Caramelli, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Heart Institute - University of Sao Paulo

Gabriel A Carmo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Heart Institute - University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Carmo GA, Calderaro D, Gualandro DM, Pastana AF, Yu PC, Marques AC, Caramelli B. The Ankle-Brachial Index is Associated With Cardiovascular Complications After Noncardiac Surgery. Angiology. 2016 Feb;67(2):187-92. doi: 10.1177/0003319715589684. Epub 2015 Jun 9.

Reference Type DERIVED
PMID: 26058673 (View on PubMed)

Other Identifiers

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USP - 0175/11

Identifier Type: -

Identifier Source: org_study_id