Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907439
• Other study ID #: WU-HRPO-07-0551
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: November 3, 2010
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-emergent coronary bypass grafting surgery

• Left ventricular ejection fraction of 40% or greater

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diastolic Dysfunction
• General Anesthesia
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Boskovski MT, Shmuylovich L, Kovács 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. — View Citation

Shmuylovich L, Kovács 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. Epub 2006 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator)		Following induction of volatile anesthesia	No
Secondary	Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator)		Following the onset of controlled ventilation	No