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AnesthesiaNCT03122600

Ankle Brachial Index Versus Conventional Cardiac Risk Indices

An observational study of Anesthesia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Anesthesia
How many people
100 participants
Where
No sites listed yet
Study dates
1 May 2017to 1 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

mohammed S abd el aal, MSc contact

1001204222 ext. +20

Saikl_2015@hotmail.com

About this study

Official title: 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.

Read the 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

Conditions
Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03122600
Study groupRoleWhat they receive
vascular surgery groupElderly patients undergoing vascular surgery in the lower half of the body

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. myocardial ischemia

    incidence of myocardial ischemia after operation

    Measured: up to 7 days postoperative

Secondary outcomes (2)
  1. myocardial infarction

    incidence of myocardial infarction after operation

    Measured: up to 7 days postoperative

  2. mortality

    incidence of mortality related to cardiac problems

    Measured: up to 7 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2017
  2. Study start1 May 2017 (estimated)
  3. Primary completion1 May 2018 (estimated)
  4. Study completion1 May 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03122600
Sponsor's protocol ID
IRB0000
Status last verified
Apr 2017
First submitted
18 Apr 2017
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mohammed S abd el aal, MSc (1001204222 ext. +20, Saikl_2015@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

myocardial ischemia (time frame: up to 7 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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