SPY Imaging System: Its Role in Pediatric Cardiac Surgery

NCT00446927 | Completed

• 1 other identifier: IRB00001298
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass; Congenital Heart Defects

Keywords

Pediatrics; Cardiology; Cardiopulmonary Bypass; Heart Surgery; Cardiac Catheterization; Echocardiography; Imaging; ICG green dye

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study patients will be consented in the pre-operative clinic, Cardiac Intesive Care unit or from the Cardiac Step-down Unit.

You may qualify if:

• 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
• Blalock-Taussig shunt
• Right ventricle-to-pulmonary artery shunt
• Cavopulmonary shunt
• Branch or distal pulmonary artery reconstruction
• Unifocalization of aortopulmonary collaterals

You may not qualify if:

• Known sensitivity to ICG, iodides or shellfish
• Inability to obtain informed consent
• \> 18 years of age

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (5)

• 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.

  PMID: 8996315 BACKGROUND

• Tanel 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.

  PMID: 7611150 BACKGROUND

• Bonnet 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.

  PMID: 8868989 BACKGROUND

• Ibarra-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.

  PMID: 5785157 BACKGROUND

• Parsons 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.

  PMID: 5908418 BACKGROUND

Related Links

• Click here for more information about the SPY Imaging System

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Brian Kogon, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, surgery

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 13, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

US (1)