- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275220
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Assiut, Egypt, 17642
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
• Patients will undergo elective CABG in Assiut university hospital
Exclusion criteria:
- Poor echo window.
- Refusal of the patient
- Patients with prior RV dysfunction.
- Patients with LV dysfunction (EF:<40%).
Study Plan
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
Sponsor
Investigators
- Study Chair: Salah Atta, Professor
- Study Chair: Salma Taha, lecturer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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