Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University

September 5, 2017 updated by: Mero Fouad, Assiut University
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University

Study Overview

Detailed Description

Right ventricular (RV) dysfunction is a major risk factor in coronary artery disease (CAD) and patient undergoing revascularization with this combination , incidence of RV dysfunction is reported in about 20% cases of CAD.

RV dysfunction is a possible cause of cardiac failure after cardiac surgery and has a high mortality rate.

RV dysfunction is a recognized cause of hypotension early after coronary artery bypass graft surgery (CABG)

A decrease in RV function is an event known to occur after CABG. Right ventricular dysfunction can be seen during and immediately after cardiac surgery. Although the mechanism of this phenomenon is not well understood, cardiopulmonary bypass, perioperative myocardial ischemia, intraoperative myocardial damage, cardioplegia, and pericardial disruption or adhesion have been suggested as probable causes.

Major reasons for complications of cardiac surgery are the need for hypothermic cardiac arrest, aortic cross clamping, and exposure to a cardiopulmonary bypass circuit.

It has been postulated that avoidance of these factors by performing off-pump coronary artery bypass (OPCAB) surgery might reduce perioperative morbidity and improve outcome.

Recently, the portion of coronary artery bypass grafting on the beating heart without the use of cardiopulmonary bypass (CPB) has been expanded in cardiac surgery as a result of awareness of the damaging effect of CPB

Whether OPCAB surgery can fulfill these expectations, or to which degree, is yet unclear.

A few studies on hemodynamic alternations associated with OPCAB reported that reduced functions of both ventricles during coronary artery anastomosis are the main mechanism of hemodynamic derangements and especially, impaired diastolic function of the right ventricle (RV) plays an important role

However, clinical studies evaluating the change in RV function in patients with ischemic heart disease are very rare. It is reported that the major cause of hemodynamic changes during OPCAB was disturbed diastolic filling of the RV through the measurement of chamber pressures or monitoring of echocardiography.

There was no significant change in the RVEF and cardiac index during anastomosis of the left anterior descending artery and right coronary artery. However, the significantly reduced RVEF accompanied by an increase in RV afterload and decrease in the CO was observed during anastomosis of the obtuse marginal (OM) artery. RV volumes did not significantly change during anastomoses, though the right atrial pressure increased during anastomoses of all coronary arteries. The displacement of beating heart for positioning during anastomosis of the graft to OM artery caused significant derangement of RV function and decrease in CO.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt, 17642
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include patients will undergo elective CABG of different ages from cardiology department, Assiut University Hospital

Description

  1. Inclusion criteria:

    • Patients will undergo elective CABG in Assiut university hospital

  2. Exclusion criteria:

    • Poor echo window.
    • Refusal of the patient
    • Patients with prior RV dysfunction.
    • Patients with LV dysfunction (EF:<40%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of effects of CABG on right ventricular function
Time Frame: 6 months
assessment of right ventricular function in patients undergoing CABG using 2D echocardiography and 3D echocardiography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Salah Atta, Professor
  • Study Chair: Salma Taha, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 10, 2017

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

August 27, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 17100309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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