SPY Imaging System: Its Role in Pediatric Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Brian Kogon, Emory University
ClinicalTrials.gov Identifier:
NCT00446927
First received: March 8, 2007
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition
Cardiopulmonary Bypass
Congenital Heart Defects

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SPY Imaging System: Its Role in Pediatric Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Emory University:

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known sensitivity to ICG, iodides or shellfish
  • Inability to obtain informed consent
  • > 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446927

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Brian Kogon, MD Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Brian Kogon, Associate professor, surgery, Emory University
ClinicalTrials.gov Identifier: NCT00446927     History of Changes
Other Study ID Numbers: IRB00001298
Study First Received: March 8, 2007
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
Pediatrics
Cardiology
Cardiopulmonary Bypass
Heart Surgery
Cardiac Catheterization
Echocardiography
Imaging
ICG green dye

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014