Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446927
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2007-03-08
Brief Title:
SPY Imaging System Its Role in Pediatric Cardiac Surgery
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
SPY Imaging System Its Role in Pediatric Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current method of evaluating the surgical repair during surgery is limited to echocardiography a noninvasive diagnostic procedure that uses ultrasound to study the structure and motions of the heart or an invasive procedure called cardiac catheterization
The SPY imaging system makes use of the fluorescence properties of indocyanine green ICG to obtain high quality images in blood vessels ICG is a green dye used to test heart output The use of the SPY imaging system during surgery may provide valuable information regarding successful vessel connection and the area remaining unblocked
This study will compare the results of images to echocardiography and conventional angiography results
With SPY imaging congenital heart surgeons would be able to check the quality of the procedure and revise redo or perform additional procedures as dictated by the images before the patient leaves the operating room
The SPY imaging system makes use of the fluorescence properties of indocyanine green ICG to obtain high quality images in blood vessels ICG is a green dye used to test heart output The use of the SPY imaging system during surgery may provide valuable information regarding successful vessel connection and the area remaining unblocked
This study will compare the results of images to echocardiography and conventional angiography results
With SPY imaging congenital heart surgeons would be able to check the quality of the procedure and revise redo or perform additional procedures as dictated by the images before the patient leaves the operating room
Detailed Description:
It would be advantageous to detect potential problems with vessel and anastomotic patency prior to leaving the operating room The SPY imaging system makes use of the fluorescence properties of Indocyanine Green ICG to obtain high quality images of blood vessels Unlike conventional angiography indocyanine green fluorescence imaging offers the potential for a reliable non invasive inexpensive and rapid method of intraoperative assessment of vessel and anastomotic patency
This type of imaging resource could be invaluable in a repair such as
1 coronary artery re-implantation following arterial switch procedure for transposition of the great arteries anomalous coronary artery from the pulmonary artery repair or aortic root replacement
2 coarctation of the aorta
3 Blalock-Taussig shunt right-ventricle-to-pulmonary artery shunt or cavopulmonary connection for single ventricle palliation and
4 branch or distal pulmonary artery reconstructionunifocalization in tetralogy of Fallot and pulmonary atresiaventricular septal defect
The SPY imaging system is feasible for a variety of congenital heart defects and can provide valuable information regarding vessel and anastomotic patency
Specific Aim 1 Evaluate quality of images for clarity and ability to visualize desired anatomic area
Specific Aim 2 Compare results of images to echocardiography and conventional angiography results
Part 1 Compare the results of pre-repair intra-operative SPY images to preoperative echocardiography results and cardiac catheterization results when available
Part 2 Compare the results of post-repair intraoperative SPY images to postoperative echocardiography results and cardiac catheterization results when available
Approximately 40 patients in total will be enrolled in the study - 10 who have undergone coronary reimplantation 10 who have undergone repair of coarctation of the aorta 10 who have undergone a palliative shunting procedure and 10 who have undergone pulmonary artery reconstruction
Echocardiography
Preoperative intraoperative and postoperative cardiac catheterization reports will be analyzed
Cardiac catheterization
Preoperative and postoperative cardiac catheterization reports will be analyzed
SPY imaging
ICG green will be administered in the following doses 125 mg in infants 1 year 25 mg in children 16 years and 5 mg in adult size patients 17-18 years of age Doses will be injected in 1 ml volumes directly into the aorta right ventricle or pulmonary artery depending upon the procedure Repeat dosing and imaging may be performed if needed The total dose of dye will be limited to 2 mgkg Images will be obtained in the operating room prior to commencing and after weaning from cardiopulmonary bypass
This type of imaging resource could be invaluable in a repair such as
1 coronary artery re-implantation following arterial switch procedure for transposition of the great arteries anomalous coronary artery from the pulmonary artery repair or aortic root replacement
2 coarctation of the aorta
3 Blalock-Taussig shunt right-ventricle-to-pulmonary artery shunt or cavopulmonary connection for single ventricle palliation and
4 branch or distal pulmonary artery reconstructionunifocalization in tetralogy of Fallot and pulmonary atresiaventricular septal defect
The SPY imaging system is feasible for a variety of congenital heart defects and can provide valuable information regarding vessel and anastomotic patency
Specific Aim 1 Evaluate quality of images for clarity and ability to visualize desired anatomic area
Specific Aim 2 Compare results of images to echocardiography and conventional angiography results
Part 1 Compare the results of pre-repair intra-operative SPY images to preoperative echocardiography results and cardiac catheterization results when available
Part 2 Compare the results of post-repair intraoperative SPY images to postoperative echocardiography results and cardiac catheterization results when available
Approximately 40 patients in total will be enrolled in the study - 10 who have undergone coronary reimplantation 10 who have undergone repair of coarctation of the aorta 10 who have undergone a palliative shunting procedure and 10 who have undergone pulmonary artery reconstruction
Echocardiography
Preoperative intraoperative and postoperative cardiac catheterization reports will be analyzed
Cardiac catheterization
Preoperative and postoperative cardiac catheterization reports will be analyzed
SPY imaging
ICG green will be administered in the following doses 125 mg in infants 1 year 25 mg in children 16 years and 5 mg in adult size patients 17-18 years of age Doses will be injected in 1 ml volumes directly into the aorta right ventricle or pulmonary artery depending upon the procedure Repeat dosing and imaging may be performed if needed The total dose of dye will be limited to 2 mgkg Images will be obtained in the operating room prior to commencing and after weaning from cardiopulmonary bypass
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None