Clinical trial NCT01452282: Ankle-Brachial Index Estimating Cardiac Complications After Surgery
Official title: Ankle-Brachial Index Estimating Cardiac Complications After Non-Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Complications
Myocardial Infarction
Acute Coronary Syndromes
Keywords: Ankle Brachial Index
Perioperative care
General Surgery
Acute Coronary Syndromes
Cardiovascular Complications
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-10-14
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Major Cardiovascular Events
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: Heart Institute - University of Sao Paulo
name: Bruno Caramelli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute - University of Sao Paulo
name: Gabriel A Carmo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.