Ankle Brachial Index Versus Conventional Cardiac Risk Indices

NCT ID: NCT03122600

Last Updated: 2017-04-21

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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vascular surgery group

Elderly patients undergoing vascular surgery in the lower half of the body

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Sayed Abd El Aal

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esam Abd Allah

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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mohammed S abd el aal, MSc

Role: CONTACT

1001204222 ext. +20

Other Identifiers

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IRB0000

Identifier Type: -

Identifier Source: org_study_id

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