Ankle Brachial Index Versus Conventional Cardiac Risk Indices

April 20, 2017 updated by: Mohammed Sayed Abd El Aal, Assiut University

Ankle Brachial Index (ABI) Versus Conventional Cardiac Risk Indices To Predict Cardiac Affection In High Risk Patients Under General Anesthesia

the applicability of ankle brachial index (ABI) and B-type natriuretic peptide (BNP) measurement as cardiovascular risk prediction models during hospital stay in elderly patients undergoing vascular surgery.

Study Overview

Status

Unknown

Conditions

Detailed Description

A major public health challenge is therefore to accurately identify, in an apparently healthy population, those who are at high risk and to target prevention at these individuals. Although primary prevention measures, including aspirin, have been suggested for all individuals with an estimated intermediate to high cardiovascular risk of 2% per year, the best method of identifying such individuals has not been established. In addition, models based on conventional risk factors have been shown to have limited predictability and several restrictions. They were not designed for people with preexisting cardiovascular disease (CVD), and when risk factors are at extreme levels, the equations may underestimate or overestimate risk. In this regard, interest is increasing in the use of noninvasive markers that allow the identification of sub-clinical atherosclerosis, including the ankle brachial index (ABI), ratio of ankle to arm systolic blood pressure). Although quick and easy to perform with a high patient acceptability, the ABI was originally used to identify lower-limb atherosclerosis. However, it has subsequently been shown to be an accurate and reliable marker of generalized atherosclerosis. Cohort studies between 5 and 10 years of follow-up have shown that people with a low ABI have an increased risk of both cardiovascular morbidity and mortality. They have previously reported that the 5-year incidence of total cardiovascular events in subjects with an ABI ˂ 0.9 was almost twice that in subjects with an ABI ˃ 0.9 Furthermore, examination of positive predictive values showed that a low ABI was better at predicting risk of future cardiovascular and cerebrovascular events than conventional risk factors alone.

B-type natriuretic peptide (BNP) is a cardiac neuro-hormone secreted from membrane granules in the cardiac ventricles as a response to ventricular volume expansion and pressure overload. The natriuretic peptide system allows the heart to participate in the regulation of vascular tone and extracellular volume status. The natriuretic peptide system and the renin angiotensin system counteract each other in arterial pressure regulation. Levels of atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) are elevated in cardiac disease states associated with increased ventricular stretch. The main circulating and storage form of BNP is 32 amino acid peptide with a ring structure. Physiological actions of BNP are mediated through a guanylate cyclase-linked receptor, natriuretic peptide receptor A (NPR-A). BNP produces arterial and venous vasodilatation. Clearance of BNP is promoted by a natriuretic peptide receptor C (NPR-C) which removes it from the circulation and BNP is also degraded through enzymatic cleavage by neutral endopeptidase. BNP levels are reflective of left ventricular diastolic filling pressures and thus correlate with pulmonary capillary wedge pressure.

BNP levels have been shown to be elevated in patients with symptomatic left ventricular dysfunction and correlate with New York Heart Association (NYHA) classification and prognosis.

Based on the available information a BNP < 100 pg/ml, allows clinicians to exclude heart failure as a cause of the patients' symptoms or physical exam signs in most circumstances BNP levels have been shown to predict long term mortality in patients with heart failure, independent of other established prognostic variable

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

elderly patients, undergoing vascular surgery in the lower half of the body under general anesthesia

Description

Inclusion Criteria:

  • Patients 60 years or older
  • American Society of Anesthesiologists (ASA) III or IV
  • Operation in the lower half of the body

Exclusion Criteria:

  • Patient refusal
  • Patient with acute cardiac condition (MI, recent MI ,sever valve lesion or heart failure)

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

Cohorts and Interventions

Group / Cohort
vascular surgery group
Elderly patients undergoing vascular surgery in the lower half of the body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial ischemia
Time Frame: up to 7 days postoperative
incidence of myocardial ischemia after operation
up to 7 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial infarction
Time Frame: up to 7 days postoperative
incidence of myocardial infarction after operation
up to 7 days postoperative
mortality
Time Frame: up to 7 days postoperative
incidence of mortality related to cardiac problems
up to 7 days postoperative

Collaborators and Investigators

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

Investigators

  • Study Director: Esam Abd Allah, Assiut University

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 (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB0000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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