An observational study in Tetralogy of Fallot, sponsored by Assiut University. Status unknown at 2 sites in Egypt. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Assiut University · Observational
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This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
The shape of the RV is dramatically modified by surgical repair of CHD, with infundibular bulging and apical dilation and deformation, leading to a large range of RV shapes(1,2). Moreover, pericardial section and suture during surgery influence RV geometry, as RV is normally more con-strained by the pericardium then the LV because of its thinner wall (3).
Intra cardiac repair(ICR) is the definitive management of TOF. Refinement in surgical techniques, advancements in anaesthetic \& critical care has resulted in improving survival following ICR. Post operative mortality following ICR is reported between 1% - 5% (3). Post operative low cardiac output and mortality has been attributed to many factors such as anatomical defects with small main pulmonary artery annulus, severe hypoplasia or absent right or left pulmonary artery, ventriculotomy and right ventricular (RV) outflow patch, myocardial hypoxia during cardiopulmonary bypass, or ARDS (4). Certain patients despite satisfactory ICR exhibit difficult post operative course which is characterized by prolonged ventilation \& inotropic support. These patients have been identified to exhibit features of RV dysfunction (low cardiac output, high central venous filling pressure, increased inotropic requirement, and prolonged ventilation). Identification of risk factors to characterise this subset of patients allows for better allocation of hospital resources, improved outcome, and substantially reduced hospital costs. This study will try to identify the risk factors associated with development of RV dysfunction \& its course over a period of three months in patients of tetralogy following ICR.
MRI is a gold standard for assessment of right ventricular function (5). However, MRI has restricted availability, is costly, and there are many patients in whom MRI-non compatible devices prohibit its use.
Because of its complex shape, there is no geometrical assumption that can allow quantification of RV volumes and ejection fraction (RVEF) by standard two-dimensional (2D) echocardiography. For this reason, surrogate parameters of RV systolic function are used most frequently to assess RV systolic function, because they are easy to measure, feasible and reproducible. These parameters include:-
-2D global longitudinal peak systolic strain of the RV lateral wall:- Speckle-tracking echocardiography is a new technology that allows quantification of myocardial regional deformation. The main advantage compared with tissue Doppler imaging is its angle independency; it was also thought to be less load dependent, but further studies demonstrated that 2D longitudinal strain values increase in volume overload and decrease in barometric overload (7).
-Myocardial performance index :- Myocardial performance index (MPI) is another tissue Doppler-derived parameter of RV systolic function. MPI is calculated using the following formula: MPI =(isovolumic contraction time + isovolumic relaxation time)/ejection time (10).
92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 40 observational studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with tetralogy of Fallot who are indicated to palliative procedures and not for definitive surgical repair as in case of:-
Patients with TOF who are to primary repair as in case of:-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All pediatric patients who present to pediatric cardiothoracic unit, Assiut University Hospital and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their surgical procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis
Assessment of RV function early after surgical repair of tetralogy of fallot
the study aim to assess the function of the Right ventricle early after surgical repair of tetralogy of fallot by echocardiography.
Time frame: within one week postoperative
Follow up the course of RV function over a period of three months in patients of tetralogy of fallot following surgical repair .
the study aim to follow up the function of the Right ventricle after surgical repair of tetralogy of fallot by echocardiography
Time frame: 3 months postoperative
Plan to share: Undecided — This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
Started Apr 2018 (actual). Primary completion is estimated for Sep 2022, 53 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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