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Ischemia Coronary Artery OriginNCT03719248

Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery

A study testing thoracic epidural in people with Ischemia Coronary Artery Origin, run by Ahmed Said Elgebaly,MD at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic… Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Ischemia Coronary Artery Origin
What is being tested?
thoracic epidural
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Jan 2017to 1 Jan 2018
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 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • patients between 65 and 75 years with:
  • physical status of ASA II and IV
  • who underwent aortic valve replacement (for isolated or mixed aortic valve lesions) alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic Surgery Department of Tanta University Hospital during a two year period were enrolled in this study.
  • Before inclusion in the study, all patients were evaluated with extended echocardiographic imaging, full history including cardiac symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms) was taken from all patients. General (including body weight and height) and systematic (including cardiac examination) examinations were done to all patients.

Who cannot join

  • Patients with an ejection fraction of 0.3, myocardial infarction within the last 4 weeks
  • diabetes
  • severe pulmonary or arterial hypertension.
  • a contraindication for HTEA.
  • patients without preoperative optimal echocardiographic imaging were excluded.
  • Among the exclusion criteria were the administration of ticlopidine within 15 days before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In common with previous investigators, we did not consider treatment with low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be contraindications to the procedure.
  • Patients with significant aortic insufficiency were also excluded from the study in order to avoid introducing further variables that could influence hemodynamic response to the procedure.
  • Patients were excluded if they underwent an AVR on an emergency basis, had poor acoustic windows for adequate echocardiographic assessment, and/or did not undergo an echocardiogram before the operation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ahmed Said Elgebaly

    Tanta

Other trials in Egypt

About this study

Official title: High Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index and Coronary Vascular Disease During Aortic Valve Replacement Alone or in Addition to Coronary Artery Bypass Graft Surgery

Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG). It Designs as A prospective randomized controlled comparative study in which eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).

Read the detailed description

Background: Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).

Aim: to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG).

Design: A prospective randomized controlled comparative study. Methods: Eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).Perioperative heart rate (HR), mean arterial blood pressure (MAP), incidence of ischemic ECG, LV systolic and diastolic function changes were measured till 48 h, postoperatively.

Patients were subjected to ambulatory Holter monitoring, Hemodynamic measures, intraoperative transesophageal echocardiography (iTEE) and postoperative Trans Thoracic Echocardiography (TTE) to assess myocardial ischemia and Left ventricular systolic/diastolic function.

Being tested
thoracic epidural
Keywords
Epidural., ventricular mass, Aortic valve, coronary bypass

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thoracic epiduralDevice

    Also called high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal and transthoracic echocardiography, Holter ECG

    high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG

Study groups in NCT03719248
Study groupRoleWhat they receive
HTEA Group + N(LVMI)+ AVR alone(n=10)Active comparatorHTEA Group + N(LVMI)+ AVR alone(n=10)
Receives: Device: thoracic epidural
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)Active comparatorHTEA Group + ↑ (LVMI)+ AVR alone(n=10)
Receives: Device: thoracic epidural
HTEA Group + N(LVMI)+ AVR + CABG(n=10)Active comparatorHTEA Group + N(LVMI)+ AVR + CABG(n=10)
Receives: Device: thoracic epidural
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)Active comparatorHTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
Receives: Device: thoracic epidural
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)No interventionControl(GA) Group+ N(LVMI)+ AVR alone(n=10)
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)No interventionControl(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10)No intervention(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)No interventionControl(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The changes in LV systolic.

    LV end systolic diameter (LVESD)

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.

  2. The changes in LV diastolic.

    Left ventricular end diastolic diameter (LVEDD)

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.

  3. ejection fraction percent

    changes in percentage, of how much blood the left ventricle pumps out with each contraction.

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.

  4. FAC percent

    Fractional Area Change (FAC) percent

    Fractional Area Change (FAC)

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.

  5. EDA

    end-diastolic area (EDA)

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.

Secondary outcomes (3)

  1. Perioperative changes in heart rate (HR).

    during evaluation of hemodynamic changes.

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively

  2. changes in mean arterial blood pressure (MAP)

    during evaluation of hemodynamic changes.

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively

  3. the changes incidence of ischemic ECG.

    Holter monitor tapes were analyzed for myocardial ischemia based the criteria of horizontal or down-sloping ST-segment depression of > 1 mm below the baseline, lasting for at least 1 min. Events were separated by at least 5 min without ECG ischemia ECG changes included new ST-T changes, T inversion, Q waves and/or a bundle branch block

    Measured: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start1 Jan 2017
  3. Primary completion1 Jan 2018
  4. Study completion1 Jan 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719248
Sponsor's protocol ID
TantaU
Status last verified
Oct 2018
First submitted
15 Oct 2018
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schmidt C, Hinder F, Van Aken H, Theilmeier G, Bruch C, Wirtz SP, Burkle H, Guhs T, Rothenburger M, Berendes E. The effect of high thoracic epidural anesthesia on systolic and diastolic left ventricular function in patients with coronary artery disease. Anesth Analg. 2005 Jun;100(6):1561-1569. doi: 10.1213/01.ANE.0000154963.29271.36.

    PubMed 15920175

  • Berendes E, Schmidt C, Van Aken H, Hartlage MG, Wirtz S, Reinecke H, Rothenburger M, Scheld HH, Schluter B, Brodner G, Walter M. Reversible cardiac sympathectomy by high thoracic epidural anesthesia improves regional left ventricular function in patients undergoing coronary artery bypass grafting: a randomized trial. Arch Surg. 2003 Dec;138(12):1283-90; discussion 1291. doi: 10.1001/archsurg.138.12.1283.

    PubMed 14662525

  • Blomberg S, Emanuelsson H, Kvist H, Lamm C, Ponten J, Waagstein F, Ricksten SE. Effects of thoracic epidural anesthesia on coronary arteries and arterioles in patients with coronary artery disease. Anesthesiology. 1990 Nov;73(5):840-7. doi: 10.1097/00000542-199011000-00008.

    PubMed 2240673

  • Svircevic V, Nierich AP, Moons KG, Diephuis JC, Ennema JJ, Brandon Bravo Bruinsma GJ, Kalkman CJ, van Dijk D. Thoracic epidural anesthesia for cardiac surgery: a randomized trial. Anesthesiology. 2011 Feb;114(2):262-70. doi: 10.1097/ALN.0b013e318201d2de.

    PubMed 21239976

  • Conrady AO, Rudomanov OG, Zaharov DV, Krutikov AN, Vahrameeva NV, Yakovleva OI, Alexeeva NP, Shlyakhto EV. Prevalence and determinants of left ventricular hypertrophy and remodelling patterns in hypertensive patients: the St. Petersburg study. Blood Press. 2004;13(2):101-9. doi: 10.1080/08037050410031855.

    PubMed 15182113

  • Guarracino F, Cariello C, Tritapepe L, Doroni L, Baldassarri R, Danella A, Stefani M. Transoesophageal echocardiography during coronary artery bypass procedures: impact on surgical planning. HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(1):43-9.

    PubMed 23440403

  • El-Morsy GZ, El-Deeb A. The outcome of thoracic epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery. Saudi J Anaesth. 2012 Jan;6(1):16-21. doi: 10.4103/1658-354X.93048.

    PubMed 22412771

  • Crescenzi G, Landoni G, Monaco F, Bignami E, De Luca M, Frau G, Rosica C, Zangrillo A. Epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2009 Dec;23(6):807-12. doi: 10.1053/j.jvca.2009.02.003. Epub 2009 Apr 19.

    PubMed 19376734

  • Devereux RB, Reichek N. Echocardiographic determination of left ventricular mass in man. Anatomic validation of the method. Circulation. 1977 Apr;55(4):613-8. doi: 10.1161/01.cir.55.4.613.

    PubMed 138494

  • Orsinelli DA, Aurigemma GP, Battista S, Krendel S, Gaasch WH. Left ventricular hypertrophy and mortality after aortic valve replacement for aortic stenosis. A high risk subgroup identified by preoperative relative wall thickness. J Am Coll Cardiol. 1993 Nov 15;22(6):1679-83. doi: 10.1016/0735-1097(93)90595-r.

    PubMed 8227838

Questions about this trial

What is this clinical trial studying?

A study testing thoracic epidural in people with Ischemia Coronary Artery Origin, run by Ahmed Said Elgebaly,MD 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 4 inclusion and 8 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 25 Oct 2018. 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?

The changes in LV systolic. (time frame: 5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.). The study lists 5 primary outcomes in all. 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 NCT03719248, which also lists 10 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 25 Oct 2018.

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