Cardiopulmonary BypassNCT00446927
SPY Imaging System: Its Role in Pediatric Cardiac Surgery
An observational study of Cardiopulmonary Bypass and Congenital Heart Defects, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiopulmonary Bypass, Congenital Heart Defects
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jan 2012
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study patients will be consented in the pre-operative clinic, Cardiac Intesive Care unit or from the Cardiac Step-down Unit.
Who may be able to join
- Patients undergoing congenital heart operations at Children's Healthcare of Atlanta.
- Less than or equal to 18 years of age.
- Arterial switch procedure
- Anomalous coronary artery from the pulmonary artery repair
- Aortic root replacement
- Coarctation of the aorta repair
Show all 11Show fewer
- Blalock-Taussig shunt
- Right ventricle-to-pulmonary artery shunt
- Cavopulmonary shunt
- Branch or distal pulmonary artery reconstruction
- Unifocalization of aortopulmonary collaterals
Who cannot join
- Known sensitivity to ICG, iodides or shellfish
- Inability to obtain informed consent
- > 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
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.
Read more
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.
Read the 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:
- 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,
- coarctation of the aorta,
- Blalock-Taussig shunt, right-ventricle-to-pulmonary artery shunt, or cavopulmonary connection for single ventricle palliation, and
- branch or distal pulmonary artery reconstruction/unifocalization in tetralogy of Fallot and pulmonary atresia/ventricular 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: 1.25 mg in infants (< 1 year), 2.5 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 mg/kg. Images will be obtained in the operating room prior to commencing and after weaning from cardiopulmonary bypass.
- Conditions
- Cardiopulmonary Bypass, Congenital Heart Defects
- Keywords
- Pediatrics, Cardiology, Cardiopulmonary Bypass, Heart Surgery, Cardiac Catheterization, Echocardiography, Imaging, ICG green dye
- Medical subject headings
- Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Emory 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Brian Kogon, Emory University
- Investigators
- Brian Kogon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446927
- Sponsor's protocol ID
- IRB00001298
- Status last verified
- May 2012
- First submitted
- 8 Mar 2007
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonhoeffer P, Bonnet D, Piechaud JF, Stumper O, Aggoun Y, Villain E, Kachaner J, Sidi D. Coronary artery obstruction after the arterial switch operation for transposition of the great arteries in newborns. J Am Coll Cardiol. 1997 Jan;29(1):202-6. doi: 10.1016/s0735-1097(96)00433-0.
PubMed 8996315Tanel RE, Wernovsky G, Landzberg MJ, Perry SB, Burke RP. Coronary artery abnormalities detected at cardiac catheterization following the arterial switch operation for transposition of the great arteries. Am J Cardiol. 1995 Jul 15;76(3):153-7. doi: 10.1016/s0002-9149(99)80048-4.
PubMed 7611150Bonnet D, Bonhoeffer P, Piechaud JF, Aggoun Y, Sidi D, Planche C, Kachaner J. Long-term fate of the coronary arteries after the arterial switch operation in newborns with transposition of the great arteries. Heart. 1996 Sep;76(3):274-9. doi: 10.1136/hrt.76.3.274.
PubMed 8868989Ibarra-Perez C, Castaneda AR, Varco RL, Lillehei CW. Recoarctation of the aorta. Nineteen year clinical experience. Am J Cardiol. 1969 Jun;23(6):778-84. doi: 10.1016/0002-9149(69)90371-3. No abstract available.
PubMed 5785157Parsons CG, Astley R. Recurrence of aortic coarctation after operation in childhood. Br Med J. 1966 Mar 5;1(5487):573-7. doi: 10.1136/bmj.1.5487.573. No abstract available.
PubMed 5908418
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPY Imaging System: Its Role in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00446927
- Acronym / sponsor ID
- IRB00001298
- Conditions
- Cardiopulmonary Bypass, Congenital Heart Defects
- Keywords
- Pediatrics, Cardiology, Cardiopulmonary Bypass, Heart Surgery, Cardiac Catheterization, Echocardiography, Imaging, ICG green dye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Apr 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Mar 2007 (estimated)
- 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.
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.
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:
- 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,
- coarctation of the aorta,
- Blalock-Taussig shunt, right-ventricle-to-pulmonary artery shunt, or cavopulmonary connection for single ventricle palliation, and
- branch or distal pulmonary artery reconstruction/unifocalization in tetralogy of Fallot and pulmonary atresia/ventricular 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: 1.25 mg in infants (< 1 year), 2.5 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 mg/kg. Images will be obtained in the operating room prior to commencing and after weaning from cardiopulmonary bypass.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study patients will be consented in the pre-operative clinic, Cardiac Intesive Care unit or from the Cardiac Step-down Unit.
Key inclusion criteria (11 listed)
- Patients undergoing congenital heart operations at Children's Healthcare of Atlanta.
- Less than or equal to 18 years of age.
- Arterial switch procedure
- Anomalous coronary artery from the pulmonary artery repair
- Aortic root replacement
Key exclusion criteria (3 listed)
- Known sensitivity to ICG, iodides or shellfish
- Inability to obtain informed consent
- > 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
- Background: PubMed 8996315Bonhoeffer P, Bonnet D, Piechaud JF, Stumper O, Aggoun Y, Villain E, Kachaner J, Sidi D. Coronary artery obstruction after the arterial switch operation for transposition of the great arteries in newborns. J Am Coll Cardiol. 1997 Jan;29(1):202-6. doi: 10.1016/s0735-1097(96)00433-0.
- Background: PubMed 7611150Tanel RE, Wernovsky G, Landzberg MJ, Perry SB, Burke RP. Coronary artery abnormalities detected at cardiac catheterization following the arterial switch operation for transposition of the great arteries. Am J Cardiol. 1995 Jul 15;76(3):153-7. doi: 10.1016/s0002-9149(99)80048-4.
- Background: PubMed 8868989Bonnet D, Bonhoeffer P, Piechaud JF, Aggoun Y, Sidi D, Planche C, Kachaner J. Long-term fate of the coronary arteries after the arterial switch operation in newborns with transposition of the great arteries. Heart. 1996 Sep;76(3):274-9. doi: 10.1136/hrt.76.3.274.
- Background: PubMed 5785157Ibarra-Perez C, Castaneda AR, Varco RL, Lillehei CW. Recoarctation of the aorta. Nineteen year clinical experience. Am J Cardiol. 1969 Jun;23(6):778-84. doi: 10.1016/0002-9149(69)90371-3. No abstract available.
- Background: PubMed 5908418Parsons CG, Astley R. Recurrence of aortic coarctation after operation in childhood. Br Med J. 1966 Mar 5;1(5487):573-7. doi: 10.1136/bmj.1.5487.573. No abstract available.
- Click here for more information about the SPY Imaging SystemLink provided by the sponsor.
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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.
Brian Kogon, MD principal investigator
Emory University
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 Cardiopulmonary Bypass and Congenital Heart Defects, run by Emory University at 1 site in United States.
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 11 inclusion and 3 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: finished, as of the sponsor's last update on 24 May 2012. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446927, which also lists 5 linked publications.
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 24 May 2012.