CORONARY ARTERY BYPASSNCT03275220
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University
An observational study of CORONARY ARTERY BYPASS, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CORONARY ARTERY BYPASS
- What is being tested?
- 2D Echocardiography and 3D Echocardiography
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2017to 30 Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include patients will undergo elective CABG of different ages from cardiology department, Assiut University Hospital
- 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%).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university
Asyut, 17642
Maria Refaat, master, 01120108960, Merofouad307@yahoo.com
Salah Atta
About this study
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University
Read the 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.
- Conditions
- CORONARY ARTERY BYPASS
- Being tested
- 2D Echocardiography and 3D Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D Echocardiography and 3D EchocardiographyDiagnostic test
Imaging of right ventricle by 2d echocardiography and 3D echocardiography to assess right ventricular function accurately
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of effects of CABG on right ventricular function
assessment of right ventricular function in patients undergoing CABG using 2D echocardiography and 3D echocardiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start10 Sep 2017 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
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 CORONARY ARTERY BYPASSStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mero Fouad, Assiut University
- Investigators
- Salah Atta, Study chair, professorSalma Taha, Study chair, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275220
- Sponsor's protocol ID
- 17100309
- Status last verified
- Sep 2017
- First submitted
- 27 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roshanali F, Yousefnia MA, Mandegar MH, Rayatzadeh H, Alinejad S. Decreased right ventricular function after coronary artery bypass grafting. Tex Heart Inst J. 2008;35(3):250-5.
PubMed 18941594
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University
- ClinicalTrials.gov ID
- NCT03275220
- Acronym / sponsor ID
- 17100309
- Conditions
- CORONARY ARTERY BYPASS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2017 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 7 Sep 2017 (actual)
- 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.
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include patients will undergo elective CABG of different ages from cardiology department, Assiut University Hospital
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 |
|---|---|---|
| 2D Echocardiography and 3D EchocardiographyImaging of right ventricle by 2d echocardiography and 3D echocardiography to assess right ventricular function accurately | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Background: PubMed 18941594Roshanali F, Yousefnia MA, Mandegar MH, Rayatzadeh H, Alinejad S. Decreased right ventricular function after coronary artery bypass grafting. Tex Heart Inst J. 2008;35(3):250-5.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
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.
Salah Atta study chair
professor
Salma Taha study chair
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CORONARY ARTERY BYPASS, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Refaat, master (01120108960, Merofouad307@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of effects of CABG on right ventricular function (time frame: 6 months). 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 NCT03275220, 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 7 Sep 2017.