Ankle-Brachial Index Estimating Cardiac Complications After Surgery

NCT01452282 | Completed

• 1 other identifier: USP - 0175/11
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Complications; Myocardial Infarction; Acute Coronary Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major Cardiovascular Events

  30 days after surgery

Study Arms (1)

Ankle Brachial Index

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26058673 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples will be retained for future exams.

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Bruno Caramelli, Ph.D.

  Heart Institute - University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Gabriel A Carmo, M.D.

  Heart Institute - University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute

Study Record Dates

• First Submitted: October 8, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

BR (1)