Valvular Heart DiseaseNCT01819012
Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
A study testing Isoflurane 1.0 MAC, Isoflurane 1.5 MAC and Isoflurane 2.0 MAC in people with Valvular Heart Disease and Ischemic Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Valvular Heart Disease, Ischemic Heart Disease
- What is being tested?
- Isoflurane 1.0 MAC, Isoflurane 1.5 MAC and Isoflurane 2.0 MAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Mar 2014
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing cardiac surgery
Who cannot join
- low ejection fraction < 50% in preoperative transthoracic echocardiography
- atrial fibrillation
- pacemaker
- pericardial and infiltrative myocardial disease
- mitral annular calcification, surgical rings, prosthetic mitral valves
- lateral left ventricular regional wall motion abnormality
Show all 9Show fewer
- esophageal spasm, stricture, laceration, perforation, and diverticulum diaphragmatic hernia
- history of extensive radiation to mediastinum
- upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients.
Read the detailed description
Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many studies have shown that isoflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular (LV) function.
Tissue Doppler imaging (TDI) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV long-axis function. Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the impact of isoflurane on LV systolic and diastolic function.
The investigators hypothesized that isoflurane, even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of systolic mitral annular velocity (S').
So the investigators planned to study the changes in S' of lateral mitral annulus at the clinical isoflurane dosage during remifentanil based anesthesia for cardiac surgery.
- Conditions
- Valvular Heart Disease, Ischemic Heart Disease
- Being tested
- Isoflurane 1.0 MAC, Isoflurane 1.5 MAC, Isoflurane 2.0 MAC
- Keywords
- Isoflurane, mitral valve annular velocity, tissue Doppler imaging, Monitoring, echocardiography
- Medical subject headings
- Heart Valve Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoflurane 1.0 MACDrug
10 min-inhalation of each concentration of isoflurane, 1.0 MAC
Isoflurane 1.5 MACDrug
10 min-inhalation of each concentration of isoflurane, 1.5 MAC
Isoflurane 2.0 MACDrug
10 min-inhalation of each concentration of isoflurane, 2.0 MAC
| Study group | Role | What they receive |
|---|---|---|
| Isoflurane 1.0 MAC | Experimental | 10 min-inhalation of each concentration of isoflurane, 1.0 MAC Receives: Drug: Isoflurane 1.0 MAC |
| Isoflurane 1.5 MAC | Experimental | 10 min-inhalation of each concentration of isoflurane, 1.5 MAC Receives: Drug: Isoflurane 1.5 MAC |
| Isoflurane 2.0 MAC | Experimental | 10 min-inhalation of each concentration of isoflurane, 2.0 MAC Receives: Drug: Isoflurane 2.0 MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak mitral annular velocity during systole(S')
By using pulsed Doppler with the sample volume positioned at the lateral mitral valve (MV)ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Secondary outcomes (6)
ejection fraction(EF)
By using modified Simpson technique in the midesophageal 4-chamber view, EF would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
bispectral index(BIS)
BIS would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
peak velocity of mitral inflow during early relaxation(E)
By using pulsed Doppler with the sample volume positioned at the IMV opening in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
peak velocity of mitral inflow during atrial contraction(A)
By using pulsed Doppler with the sample volume positioned at the tip of MV opening in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Peak mitral annular velocity during early diastole(E')
By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Peak mitral annular velocity during atrial contraction(A')
By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Measured: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD, PhD, Principal investigator, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819012
- Sponsor's protocol ID
- KUH1160052
- Status last verified
- Oct 2016
- First submitted
- 22 Mar 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kim JD, Son I, Kwon WK, Sung TY, Sidik H, Kim K, Kang H, Bang J, Yeo GE, Lee DK, Kim TY. Isoflurane's Effect on Intraoperative Systolic Left Ventricular Performance in Cardiac Valve Surgery Patients. J Korean Med Sci. 2018 Jan 22;33(4):e28. doi: 10.3346/jkms.2018.33.e28.
PubMed 29318795
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01819012
- Acronym / sponsor ID
- KUH1160052
- Conditions
- Valvular Heart Disease, Ischemic Heart Disease
- Keywords
- Isoflurane, mitral valve annular velocity, tissue Doppler imaging, Monitoring, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Mar 2013 (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 Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients.
Detailed description
Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many studies have shown that isoflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular (LV) function.
Tissue Doppler imaging (TDI) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV long-axis function. Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the impact of isoflurane on LV systolic and diastolic function.
The investigators hypothesized that isoflurane, even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of systolic mitral annular velocity (S').
So the investigators planned to study the changes in S' of lateral mitral annulus at the clinical isoflurane dosage during remifentanil based anesthesia for cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isoflurane 1.0 MAC | Experimental | Drug: Isoflurane 1.0 MAC10 min-inhalation of each concentration of isoflurane, 1.0 MAC |
| Isoflurane 1.5 MAC | Experimental | Drug: Isoflurane 1.5 MAC10 min-inhalation of each concentration of isoflurane, 1.5 MAC |
| Isoflurane 2.0 MAC | Experimental | Drug: Isoflurane 2.0 MAC10 min-inhalation of each concentration of isoflurane, 2.0 MAC |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing cardiac surgery
Key exclusion criteria (9 listed)
- low ejection fraction < 50% in preoperative transthoracic echocardiography
- atrial fibrillation
- pacemaker
- pericardial and infiltrative myocardial disease
- mitral annular calcification, surgical rings, prosthetic mitral valves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoflurane 1.0 MAC10 min-inhalation of each concentration of isoflurane, 1.0 MAC | Drug | Isoflurane 1.0 MAC |
| Isoflurane 1.5 MAC10 min-inhalation of each concentration of isoflurane, 1.5 MAC | Drug | Isoflurane 1.5 MAC |
| Isoflurane 2.0 MAC10 min-inhalation of each concentration of isoflurane, 2.0 MAC | Drug | Isoflurane 2.0 MAC |
Primary outcome
Peak mitral annular velocity during systole(S')
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
By using pulsed Doppler with the sample volume positioned at the lateral mitral valve (MV)ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)
6 secondary outcomes
ejection fraction(EF)
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
bispectral index(BIS)
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
peak velocity of mitral inflow during early relaxation(E)
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
peak velocity of mitral inflow during atrial contraction(A)
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Peak mitral annular velocity during early diastole(E')
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Peak mitral annular velocity during atrial contraction(A')
Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
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 2 Nov 2016.
- Derived from this study: PubMed 29318795Kim JD, Son I, Kwon WK, Sung TY, Sidik H, Kim K, Kang H, Bang J, Yeo GE, Lee DK, Kim TY. Isoflurane's Effect on Intraoperative Systolic Left Ventricular Performance in Cardiac Valve Surgery Patients. J Korean Med Sci. 2018 Jan 22;33(4):e28. doi: 10.3346/jkms.2018.33.e28.
- Individual participant dataSharing planned: No
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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.
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane 1.0 MAC, Isoflurane 1.5 MAC and Isoflurane 2.0 MAC in people with Valvular Heart Disease and Ischemic Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.
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 1 inclusion and 9 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 2 Nov 2016. 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 South Korea. 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?
Peak mitral annular velocity during systole(S') (time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC). 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 NCT01819012, which also lists 1 linked publication.
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 2 Nov 2016.