Myocardial ProtectionNCT03595111
Myocardial Biopsy in Congenital Cardiac Surgery
A study testing myocardial biopsy in people with Myocardial Protection, run by Assiut University.
Trial summary
Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Myocardial Protection
- What is being tested?
- myocardial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Dec 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes.
- Hemodynamic stability.
Who cannot join
- Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.
About this study
Official title: Does Intraoperative Myocardial Biopsy Have Any Prognostic Value in Predicting Myocardial Protection After Congenital Cardiac Surgery
Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.
Read the detailed description
Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.
- Conditions
- Myocardial Protection
- Being tested
- myocardial biopsy
- Keywords
- Cardiac Protection, Pediatric, Myocardial biopsy, Cardiopulmonary Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial biopsyProcedure or surgery
Myocardial cell edema either focal or diffuse was detected in histopathological examination
| Study group | Role | What they receive |
|---|---|---|
| Myocardial biopsy | Experimental | The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change. Receives: Procedure: myocardial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial biopsy
Myocardial cell edema either focal or diffuse was detected in histopathological examination
Measured: within 24 hours
Secondary outcomes (4)
The inotropic score
1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine.
Measured: within one month
Serum cardiac troponin level
Samples for troponin I levels at baseline, 6, 12 and 24 hours after aortic cross-clamping.
Measured: first 24 hours
30-day mortality
number of patients died
Measured: 30 days
Type of cardiac rhythm on return
Type of cardiac rhythm on return
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial ProtectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595111
- Sponsor's protocol ID
- IRB00008715964
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperative Myocardial Biopsy Have Any Prognostic Value in Predicting Myocardial Protection After Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03595111
- Acronym / sponsor ID
- IRB00008715964
- Conditions
- Myocardial Protection
- Keywords
- Cardiac Protection, Pediatric, Myocardial biopsy, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Jul 2018 (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.
Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.
Detailed description
Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout
| Arm | Type | Receives |
|---|---|---|
| Myocardial biopsy | Experimental | Procedure: myocardial biopsyThe specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes.
- Hemodynamic stability.
Key exclusion criteria (1 listed)
- Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.
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 |
|---|---|---|
| myocardial biopsyMyocardial cell edema either focal or diffuse was detected in histopathological examination | Procedure or surgery | Myocardial biopsy |
Primary outcome
Myocardial biopsy
Time frame: within 24 hours
Myocardial cell edema either focal or diffuse was detected in histopathological examination
4 secondary outcomes
The inotropic score
Time frame: within one month
Serum cardiac troponin level
Time frame: first 24 hours
30-day mortality
Time frame: 30 days
Type of cardiac rhythm on return
Time frame: within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: No
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Myocardial Protection
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing myocardial biopsy in people with Myocardial Protection, run by Assiut University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Myocardial biopsy (time frame: within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2018.