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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-0276 | Other Identifier | HS IRB | |
| SMPH/SURGERY/CARDIOTHORACIC | Other Identifier | A539782 |
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The purpose of this study is to evaluate the correlation between fluid volume status and right ventricular volume and function, in those with free pulmonary valve insufficiency after Tetralogy of Fallot (TOF) repair.
The purpose of this study is to measure the changes in Right Ventricular size and function with changes in preload, using cardiovascular magnetic resonance (CMR). Based on an intensive research and clinical observations the investigators hypothesize that changes in volume status cause a statistically significant difference in the Cardiovascular magnetic resonance (CMR) measured RV End Diastolic Volume (EDV), end-systolic volume (ESV), ejection fraction (EF) and pulmonary regurgitation (PR). The investigator hypothesizes that smaller changes will occur in left ventricular LV EDV, ESV, and EF.
This study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Procedures include: Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Magnetic Resonance Imaging (CMRI) | Procedure | There will be 2 CMRIs. The first one will be patient's routine clinically schedule CMRI after the patient has fasted for 12 hours.This CMRI uses contrast. The second CMRI will be the research CMRI after the fluid administration. This CMRI does not use contrast. |
| Measure | Description | Time Frame |
|---|---|---|
| Postload volume status | The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters [ml]); Ejection fraction (%); pulmonary regurgitation | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have lesions predisposing to chronic volume overload (i.e. patients with significant residual postoperative ventricular septal defects (VSD), or large aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all these hemodynamic conditions can influence the late function of the right ventricle and potentially affect the response of the right side of the heart in changes in volume status
Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
Patients who have significant residual right-sided obstruction (i.e. patients who have residual RVOT obstruction or significant residual branch pulmonary artery stenosis), as it is shown that residual pulmonary stenosis may protect from RV dilation and from deterioration of the RV function.
Patients who cannot be reconstructed with a transannular patch and/or require a right ventricle to pulmonary artery homograft for reconstruction including:
Patients with renal failure and renal insufficiency
Patients with uncompensated heart failure
Cancer patients
Latex allergic patients
Patients with diabetes
Pregnant females
Prisoners
Individuals who lack consent capacity
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| Name | Affiliation | Role |
|---|---|---|
| Petros V Anagnostopoulos, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
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| Central venous line placement | Procedure | An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia. |
|
| Chest X-ray | Procedure | A chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement. |
|
| Fluid administration | Procedure | Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration. |
|
| Blood Draw | Procedure | One to two teaspoons of blood will be drawn for basic metabolic panel. |
|
| Pregnancy test | Procedure | A urine pregnancy test will be performed in female subjects. |
|
| Electrocardiogram | Procedure | 12 lead ECG |
|
| ID | Term |
|---|---|
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D055103 | Hypodermoclysis |
| D001800 | Blood Specimen Collection |
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D055104 | Infusions, Subcutaneous |
| D007263 | Infusions, Parenteral |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D005440 | Fluid Therapy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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