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出境医 / 临床实验 / Optical Tissue Identification for Myocardial Architecture (OPTIMA)

Optical Tissue Identification for Myocardial Architecture (OPTIMA)

Study Description
Brief Summary:
The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.

Condition or disease Intervention/treatment Phase
Ventricular Septal Defect Complete Atrioventricular Canal Tetralogy of Fallot With Pulmonary Stenosis Drug: Fluorescite Device: Cellvizio 100 Series System with Confocal Miniprobes Phase 2

Detailed Description:
This is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (FCM) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. Study results will be compared to a cohort of similar surgical patients following standard surgical procedures where FCM was not used. We will analyze pre-and postoperative ECGs to identify conduction abnormalities.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Subjects and the physician reading ECGs will be blinded.
Primary Purpose: Prevention
Official Title: Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022
Arms and Interventions
Arm Intervention/treatment
No Intervention: Non-imaging cohort
There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
Experimental: Imaging cohort
Up to 5mL of 1:1000 dilute fluorescite will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes. The system will be used to assist the investigator with the operative course.
 Drug: Fluorescite
1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging.
Other Name: fluorescein sodium

Device: Cellvizio 100 Series System with Confocal Miniprobes
The microscopy system will image cardiac tissue.
Outcome Measures
Primary Outcome Measures :
  1. Rate of new conduction disorders [ Time Frame: Immediately post-surgery ]
    Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups


Secondary Outcome Measures :
  1. Change in PR interval [ Time Frame: 1 year post-surgery ]
    PR interval will be compared between baseline, post-op, and 1 year follow up

  2. Change in QTc interval [ Time Frame: 1 year post-surgery ]
    QTc interval will be compared between baseline, post-op, and 1 year follow up

  3. Change in QRS interval [ Time Frame: Approximately 5 days post-surgery and 1 year post-surgery ]
    QRS interval will be compared between baseline, post-op, and 1 year follow up

  4. Degree of heart block [ Time Frame: 1 year post-surgery ]
    Degree of heart block will be assessed at post-op and 1 year follow up

  5. Pacemaker implantation [ Time Frame: 1 year post-surgery ]
    Incidence of temporary and permanent pacemaker implantation will be collected

  6. Time to temporary pacing wire removal prior to discharge [ Time Frame: Surgery to discharge (approximately 5 days) ]
    If a temporary pacing wire is placed, time to removal will be collected

  7. Residual lesion score (RLS) at discharge [ Time Frame: Surgery to discharge (approximately 5 days) ]
    RLS will be compared between groups

  8. Need for repeat bypass [ Time Frame: 1 day ]
    Need for repeat bypass for residual lesions during surgery will be collected

  9. Adverse events [ Time Frame: 1 year post-surgery ]
    Rates of adverse events will be collected and compared between the two group

  10. Ease of use [ Time Frame: 1 day ]
    Surgeon feedback regarding using the FCM system will be collected using a brief survey


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 30 days to less than 18 years old
  • Patients with planned surgical repair of:
  • Ventricular septal defect (VSD)
  • Complete atrioventricular canal (CAVC)
  • Tetralogy of Fallot (ToF) with pulmonary stenosis

Exclusion Criteria:

  • Prior history of adverse reaction to fluorescein sodium
  • Prior history of renal failure or abnormal renal function
  • Baseline PR interval > 220 msec or 98% for age
  • Baseline HR > 98% for age
  • Underlying genetic syndrome associated with progressive AV block or sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
  • Any surgical repair that requires staging or palliation
  • Pregnant or lactating
  • Exclusions specific to type of surgical repair
  • Apical muscular VSD
  • ToF with pulmonary atresia
Contacts and Locations

Contacts
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Contact: Leah Cheng 857-218-4731 leah.cheng@childrens.harvard.edu
Contact: Caroline Rogalski 857-218-5299 caroline.rogalski@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Leah Cheng    857-218-4731    leah.cheng@childrens.harvard.edu   
Principal Investigator: Aditya K Kaza, MD         
Sponsors and Collaborators
Aditya Kaza
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Aditya K Kaza, MD Boston Children's Hospital
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE December 20, 2019
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		Rate of new conduction disorders [ Time Frame: Immediately post-surgery ]
Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Change in PR interval [ Time Frame: 1 year post-surgery ]
    PR interval will be compared between baseline, post-op, and 1 year follow up
  • Change in QTc interval [ Time Frame: 1 year post-surgery ]
    QTc interval will be compared between baseline, post-op, and 1 year follow up
  • Change in QRS interval [ Time Frame: Approximately 5 days post-surgery and 1 year post-surgery ]
    QRS interval will be compared between baseline, post-op, and 1 year follow up
  • Degree of heart block [ Time Frame: 1 year post-surgery ]
    Degree of heart block will be assessed at post-op and 1 year follow up
  • Pacemaker implantation [ Time Frame: 1 year post-surgery ]
    Incidence of temporary and permanent pacemaker implantation will be collected
  • Time to temporary pacing wire removal prior to discharge [ Time Frame: Surgery to discharge (approximately 5 days) ]
    If a temporary pacing wire is placed, time to removal will be collected
  • Residual lesion score (RLS) at discharge [ Time Frame: Surgery to discharge (approximately 5 days) ]
    RLS will be compared between groups
  • Need for repeat bypass [ Time Frame: 1 day ]
    Need for repeat bypass for residual lesions during surgery will be collected
  • Adverse events [ Time Frame: 1 year post-surgery ]
    Rates of adverse events will be collected and compared between the two group
  • Ease of use [ Time Frame: 1 day ]
    Surgeon feedback regarding using the FCM system will be collected using a brief survey
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optical Tissue Identification for Myocardial Architecture
Official Title  ICMJE Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
Brief Summary The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
Detailed Description This is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (FCM) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. Study results will be compared to a cohort of similar surgical patients following standard surgical procedures where FCM was not used. We will analyze pre-and postoperative ECGs to identify conduction abnormalities.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Subjects and the physician reading ECGs will be blinded.
Primary Purpose: Prevention
Condition  ICMJE
  • Ventricular Septal Defect
  • Complete Atrioventricular Canal
  • Tetralogy of Fallot With Pulmonary Stenosis
Intervention  ICMJE
  • Drug: Fluorescite
    1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging.
    Other Name: fluorescein sodium
  • Device: Cellvizio 100 Series System with Confocal Miniprobes
    The microscopy system will image cardiac tissue.
Study Arms  ICMJE
  • No Intervention: Non-imaging cohort
    There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
  • Experimental: Imaging cohort
    Up to 5mL of 1:1000 dilute fluorescite will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes. The system will be used to assist the investigator with the operative course.
    Interventions:
    • Drug: Fluorescite
    • Device: Cellvizio 100 Series System with Confocal Miniprobes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 30 days to less than 18 years old
  • Patients with planned surgical repair of:
  • Ventricular septal defect (VSD)
  • Complete atrioventricular canal (CAVC)
  • Tetralogy of Fallot (ToF) with pulmonary stenosis

Exclusion Criteria:

  • Prior history of adverse reaction to fluorescein sodium
  • Prior history of renal failure or abnormal renal function
  • Baseline PR interval > 220 msec or 98% for age
  • Baseline HR > 98% for age
  • Underlying genetic syndrome associated with progressive AV block or sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
  • Any surgical repair that requires staging or palliation
  • Pregnant or lactating
  • Exclusions specific to type of surgical repair
  • Apical muscular VSD
  • ToF with pulmonary atresia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leah Cheng 857-218-4731 leah.cheng@childrens.harvard.edu
Contact: Caroline Rogalski 857-218-5299 caroline.rogalski@childrens.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017975
Other Study ID Numbers  ICMJE P00031701
R56HL128813 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers.
Responsible Party Aditya Kaza, Boston Children's Hospital
Study Sponsor  ICMJE Aditya Kaza
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Aditya K Kaza, MD Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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