Diastolic DysfunctionNCT00907439
Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index
An observational study of Diastolic Dysfunction and Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of inhaled anesthetic drugs upon diastolic heart function (heart suction and filling performance) in patients who are undergoing coronary bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Dysfunction, Coronary Artery Disease, General Anesthesia
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing non-emergent coronary artery bypass grafting surgery at a tertiary care center
Who may be able to join
- Non-emergent coronary bypass grafting surgery
- Left ventricular ejection fraction of 40% or greater
Who cannot join
- Myocardial infarction within 4 weeks
- Greater than mild cardiac valvular pathology
- Body mass index greater than 35
- Cardiac dysrhythmias or pacemaker therapy
- Left bundle branch block
- Uncontrolled gastroesophageal reflux disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Diastolic Dysfunction With the Onset of Volatile Anesthesia in Patients Undergoing Coronary Artery Bypass Grafting as Determined by a Load-independent Efficiency Index Derived From the Parameterized Doppler Analysis of Left Ventricular Filling
The purpose of this study is to determine the effect of inhaled anesthetic drugs upon diastolic heart function (heart suction and filling performance) in patients who are undergoing coronary bypass surgery.
Read the detailed description
Diastolic heart dysfunction is a significant cause of cardiovascular morbidity and is the cause of symptomatic heart failure in approximately one half of patients who are admitted to hospitals with heart failure symptoms. However, diastolic heart function remains difficult to measure objectively without cardiac catheterization. Diastolic heart dysfunction is also common among patients undergoing coronary bypass grafting (CABG) surgery. Despite the ubiquitous use of inhaled volatile drugs to maintain anesthesia in these patients, their effects upon diastolic heart function remain unclear.
- Keywords
- Diastole, physiopathology, coronary artery disease, volatile anesthetic, sevoflurane
- Medical subject headings
- Coronary Artery Disease, Heart Murmurs
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator)
Measured: Following induction of volatile anesthesia
Secondary outcomes (1)
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator)
Measured: Following the onset of controlled ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Troy S Wildes, MD, Principal investigator, Washington University School of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907439
- Sponsor's protocol ID
- WU-HRPO-07-0551
- Status last verified
- Nov 2010
- First submitted
- 20 May 2009
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Shmuylovich L, Kovacs SJ. Load-independent index of diastolic filling: model-based derivation with in vivo validation in control and diastolic dysfunction subjects. J Appl Physiol (1985). 2006 Jul;101(1):92-101. doi: 10.1152/japplphysiol.01305.2005. Epub 2006 Mar 30.
PubMed 16575023Boskovski MT, Shmuylovich L, Kovacs SJ. Transmitral flow velocity-contour variation after premature ventricular contractions: a novel test of the load-independent index of diastolic filling. Ultrasound Med Biol. 2008 Dec;34(12):1901-8. doi: 10.1016/j.ultrasmedbio.2008.05.002. Epub 2008 Aug 9.
PubMed 18692298
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Diastolic Dysfunction With the Onset of Volatile Anesthesia in Patients Undergoing Coronary Artery Bypass Grafting as Determined by a Load-independent Efficiency Index Derived From the Parameterized Doppler Analysis of Left Ventricular Filling
- ClinicalTrials.gov ID
- NCT00907439
- Acronym / sponsor ID
- WU-HRPO-07-0551
- Keywords
- Diastole, physiopathology, coronary artery disease, volatile anesthetic, sevoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 May 2009 (estimated)
- 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 purpose of this study is to determine the effect of inhaled anesthetic drugs upon diastolic heart function (heart suction and filling performance) in patients who are undergoing coronary bypass surgery.
Detailed description
Diastolic heart dysfunction is a significant cause of cardiovascular morbidity and is the cause of symptomatic heart failure in approximately one half of patients who are admitted to hospitals with heart failure symptoms. However, diastolic heart function remains difficult to measure objectively without cardiac catheterization. Diastolic heart dysfunction is also common among patients undergoing coronary bypass grafting (CABG) surgery. Despite the ubiquitous use of inhaled volatile drugs to maintain anesthesia in these patients, their effects upon diastolic heart function remain unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing non-emergent coronary artery bypass grafting surgery at a tertiary care center
Key inclusion criteria (2 listed)
- Non-emergent coronary bypass grafting surgery
- Left ventricular ejection fraction of 40% or greater
Key exclusion criteria (6 listed)
- Myocardial infarction within 4 weeks
- Greater than mild cardiac valvular pathology
- Body mass index greater than 35
- Cardiac dysrhythmias or pacemaker therapy
- Left bundle branch block
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
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator)
Time frame: Following induction of volatile anesthesia
1 secondary outcome
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator)
Time frame: Following the onset of controlled ventilation
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 5 Nov 2010.
- Background: PubMed 16575023Shmuylovich L, Kovacs SJ. Load-independent index of diastolic filling: model-based derivation with in vivo validation in control and diastolic dysfunction subjects. J Appl Physiol (1985). 2006 Jul;101(1):92-101. doi: 10.1152/japplphysiol.01305.2005. Epub 2006 Mar 30.
- Background: PubMed 18692298Boskovski MT, Shmuylovich L, Kovacs SJ. Transmitral flow velocity-contour variation after premature ventricular contractions: a novel test of the load-independent index of diastolic filling. Ultrasound Med Biol. 2008 Dec;34(12):1901-8. doi: 10.1016/j.ultrasmedbio.2008.05.002. Epub 2008 Aug 9.
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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.
Troy S Wildes, MD principal investigator
Washington University School of Medicine, Department of Anesthesiology
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 Diastolic Dysfunction and Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.
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 5 Nov 2010. 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 United States. 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?
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator) (time frame: Following induction of volatile anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00907439, which also lists 2 linked publications.
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 5 Nov 2010.