AnesthesiaNCT03122600
Ankle Brachial Index Versus Conventional Cardiac Risk Indices
An observational study of Anesthesia, run by Assiut University.
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.
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 group | Role | What they receive |
|---|---|---|
| vascular surgery group | Elderly 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.
myocardial ischemia
incidence of myocardial ischemia after operation
Measured: up to 7 days postoperative
Secondary outcomes (2)
myocardial infarction
incidence of myocardial infarction after operation
Measured: up to 7 days postoperative
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.
- First posted21 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Sayed Abd El Aal, Assiut University
- Investigators
- Esam Abd Allah, Study director, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Brachial Index (ABI) Versus Conventional Cardiac Risk Indices To Predict Cardiac Affection In High Risk Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03122600
- Acronym / sponsor ID
- IRB0000
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascular surgery group | – | –Elderly patients undergoing vascular surgery in the lower half of the body |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients, undergoing vascular surgery in the lower half of the body under general anesthesia
Key inclusion criteria (3 listed)
- Patients 60 years or older
- American Society of Anesthesiologists (ASA) III or IV
- Operation in the lower half of the body
Key exclusion criteria (2 listed)
- Patient refusal
- Patient with acute cardiac condition (MI, recent MI ,sever valve lesion or heart failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
myocardial ischemia
Time frame: up to 7 days postoperative
incidence of myocardial ischemia after operation
2 secondary outcomes
myocardial infarction
Time frame: up to 7 days postoperative
mortality
Time frame: up to 7 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esam Abd Allah study director
Assiut University
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.