Ischemic Heart DiseaseNCT03999463
Sevoflurane Effect on Left Atrial Performance: A Transoesophageal Echocardiographic Study
An observational study of Ischemic Heart Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
The left atrial performance is affected by the preload as well as the afterload. The LA active pumping is increased by stretching of the LA but within limits, after which the active pumping declines. The LV stiffness acts as the LA afterload. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 31 Dec 2019
- How long will I take part?
- 3 Months
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients of any sex,40-75 years, maintaining sinus rhythm undergoing elective with preserved left ventricular systolic function.
Who may be able to join
- Clinical diagnosis of ischemic heart disease
- Elective coronary artery bypass grafting.
Who cannot join
- Atrial or ventricular dysrhythmias,
- Associated mitral valve disease,
- Ejection Fraction <40%,
- Emergency coronary artery bypass grafting,
- Pericardial disease
- Contraindication to perform a TEE, e.g. Esophageal tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane Effect on Left Atrial Performance: A Transoesophageal Echocardiographic Study on Patients Undergoing Coronary Artery Bypasses Grafting
The left atrial performance is affected by the preload as well as the afterload. The LA active pumping is increased by stretching of the LA but within limits, after which the active pumping declines. The LV stiffness acts as the LA afterload. Whenever the LV stiffness increases, the overall emptying fraction becomes more pumpdependent
Read the detailed description
The echocardiographic assessment of the LA was frequently overlooked. While left atrial performance reflects both systolic and diastolic functions of the LV, it looks like more studies are being conducted to detect the effect of different interventions on the left atrial size and function. Other studies focus on the prognostic value and the ability to risk stratify different cohorts of patients, based on the early recognition of deranged LA performance.
Many studies were conducted on the effect of inhalational anesthetics on the left atrial function. Yet the results are inconclusive and sometimes contradictory. In a study on dogs, Gare Meir and his colleagues proved that desflurane, sevoflurane, and isoflurane depress left atrial contractility, delay relaxation, reduce chamber stiffness, preserve reservoir and conduit function, and impair left atrial-left ventricular coupling in vivo. Volatile anesthetics may cause impairment of both left atrial (LA) and left ventricular (LV) contractility. The mechanisms suggested were a decrease in the influx of calcium via voltage gated calcium channels as well as a decrease in calcium availability from sarcoplasmic reticulum.Echocardiographic assessment of the LA volumetric measures is comparable to that of Cardiovascular Magnetic Resonance (CMR) with clinically irrelevant difference. This makes echocardiographic assessment of LA volumes reliable, cheaperand easier to obtain.
- Conditions
- Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative transoesophageal echocardiography to test the effect of Sevoflurane on left atrial performance
Mitral inflow early diastolic velocity (meter/second)(m/s)
Measured: 30 Minutes (Start point: After induction of anesthesia and before starting sevoflurane (first set of data). End point: After achieving one MAC sevoflurane anesthesia and before skin incision (second set of data)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jul 2019
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999463
- Sponsor's protocol ID
- R 35 / 2019
- Status last verified
- Dec 2019
- First submitted
- 23 Jun 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Effect on Left Atrial Performance: A Transoesophageal Echocardiographic Study on Patients Undergoing Coronary Artery Bypasses Grafting
- ClinicalTrials.gov ID
- NCT03999463
- Acronym / sponsor ID
- R 35 / 2019
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jun 2019 (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 left atrial performance is affected by the preload as well as the afterload. The LA active pumping is increased by stretching of the LA but within limits, after which the active pumping declines. The LV stiffness acts as the LA afterload. Whenever the LV stiffness increases, the overall emptying fraction becomes more pumpdependent
Detailed description
The echocardiographic assessment of the LA was frequently overlooked. While left atrial performance reflects both systolic and diastolic functions of the LV, it looks like more studies are being conducted to detect the effect of different interventions on the left atrial size and function. Other studies focus on the prognostic value and the ability to risk stratify different cohorts of patients, based on the early recognition of deranged LA performance.
Many studies were conducted on the effect of inhalational anesthetics on the left atrial function. Yet the results are inconclusive and sometimes contradictory. In a study on dogs, Gare Meir and his colleagues proved that desflurane, sevoflurane, and isoflurane depress left atrial contractility, delay relaxation, reduce chamber stiffness, preserve reservoir and conduit function, and impair left atrial-left ventricular coupling in vivo. Volatile anesthetics may cause impairment of both left atrial (LA) and left ventricular (LV) contractility. The mechanisms suggested were a decrease in the influx of calcium via voltage gated calcium channels as well as a decrease in calcium availability from sarcoplasmic reticulum.Echocardiographic assessment of the LA volumetric measures is comparable to that of Cardiovascular Magnetic Resonance (CMR) with clinically irrelevant difference. This makes echocardiographic assessment of LA volumes reliable, cheaperand easier to obtain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients of any sex,40-75 years, maintaining sinus rhythm undergoing elective with preserved left ventricular systolic function.
Key inclusion criteria (2 listed)
- Clinical diagnosis of ischemic heart disease
- Elective coronary artery bypass grafting.
Key exclusion criteria (6 listed)
- Atrial or ventricular dysrhythmias,
- Associated mitral valve disease,
- Ejection Fraction <40%,
- Emergency coronary artery bypass grafting,
- Pericardial disease
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
intraoperative transoesophageal echocardiography to test the effect of Sevoflurane on left atrial performance
Time frame: 30 Minutes (Start point: After induction of anesthesia and before starting sevoflurane (first set of data). End point: After achieving one MAC sevoflurane anesthesia and before skin incision (second set of data)).
Mitral inflow early diastolic velocity (meter/second)(m/s)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative transoesophageal echocardiography to test the effect of Sevoflurane on left atrial performance (time frame: 30 Minutes (Start point: After induction of anesthesia and before starting sevoflurane (first set of data). End point: After achieving one MAC sevoflurane anesthesia and before skin incision (second set of data)).). 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 3 Jan 2020.