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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01452282
First received: October 8, 2011
Last updated: November 9, 2013
Last verified: November 2013
  Purpose

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.


Condition
Cardiovascular Complications
Myocardial Infarction
Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ankle-Brachial Index Estimating Cardiac Complications After Non-Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Major Cardiovascular Events [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Whole blood samples will be retained for future exams.


Enrollment: 196
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ankle Brachial Index

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01452282

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Bruno Caramelli, Ph.D. Heart Institute - University of Sao Paulo
Principal Investigator: Gabriel A Carmo, M.D. Heart Institute - University of Sao Paulo
  More Information

No publications provided

Responsible Party: Bruno Caramelli, Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01452282     History of Changes
Other Study ID Numbers: USP - 0175/11
Study First Received: October 8, 2011
Last Updated: November 9, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Ankle Brachial Index
Perioperative care
General Surgery
Acute Coronary Syndromes
Cardiovascular Complications

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 13, 2014