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Standardized Catheterization Assessment for Pulmonary Vein Stenosis

N/A

Recruiting

Led By Ryan Callahan, MD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric patients undergoing cardiac catheterization for the indication of known or suspicion for intraluminal pulmonary vein stenosis.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months +/- 6 weeks or prior to study exit due to death or lung transplant

Awards & highlights

Study Summary

This trial is testing a new, standardized way to assess pulmonary vein stenosis (narrowing). They will do this by looking at pictures of the veins, measuring pressure and compliance, and then following up 12 months later to see if the disease progressed.

Who is the study for?

This trial is for pediatric patients who are suspected to have or are known to have pulmonary vein stenosis (PVS) and are stable enough to undergo a cardiac catheterization at Boston Children's Hospital.Check my eligibility

What is being tested?

The study tests a comprehensive catheterization assessment during cardiac catheterization, including angiography, intravascular ultrasound, pressure measurement, and compliance testing. The goal is to predict PVS outcomes in children.See study design

What are the potential side effects?

While the document doesn't list specific side effects, procedures like angiography and IVUS may cause discomfort, bruising or bleeding where the catheter was inserted, allergic reactions to contrast dye used in imaging, or more rarely heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is having a heart procedure to check for narrowed lung veins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months +/- 6 weeks or prior to study exit due to death or lung transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months +/- 6 weeks or prior to study exit due to death or lung transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months +/- 6 weeks or prior to study exit due to death or lung transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary vein status

Secondary outcome measures

Patient status

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standardized catheterization assessmentExperimental Treatment1 Intervention

Assessment of pulmonary veins including angiography, intravascular ultrasound, pressure assessment and compliance testing.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,650 Total Patients Enrolled

1 Trials studying Pulmonary Vein Stenosis

5 Patients Enrolled for Pulmonary Vein Stenosis

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,580,979 Total Patients Enrolled

Ryan Callahan, MDPrincipal InvestigatorBoston Children's Hospital/Harvard Medical School

Media Library

Standardized catheterization assessment Clinical Trial Eligibility Overview. Trial Name: NCT04696289 — N/A

Pulmonary Vein Stenosis Research Study Groups: Standardized catheterization assessment

Pulmonary Vein Stenosis Clinical Trial 2023: Standardized catheterization assessment Highlights & Side Effects. Trial Name: NCT04696289 — N/A

Standardized catheterization assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04696289 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available positions in this experimental program?

"As per clinicaltrials.gov, this experiment is presently recruiting participants; the listing was first made available on February 26th 2021 and updated recently in July 8th 2022."

Answered by AI

How many participants are currently enrolled in this trial?

"Affirmative, the listing on clinicaltrials.gov confirms that this scientific investigation is currently seeking volunteers. This trial was originally posted on February 26th 2021 and has been updated most recently on July 8th 2022; 80 participants are required from 1 site."

Answered by AI

Recent research and studies

The Journal of PediatricsJournal

Adjunct Targeted Biologic Inhibition Agents to Treat Aggressive Multivessel Intraluminal Pediatric Pulmonary Vein Stenosis

Callahan, Ryan, Mark W. Kieran, Christopher W. Baird, Steven D. Colan, Kimberlee Gauvreau, Christina M. Ireland, Audrey C. Marshall, Laureen M. Sena, Sara O. Vargas, and Kathy J. Jenkins. 2018. “Adjunct Targeted Biologic Inhibition Agents to Treat Aggressive Multivessel Intraluminal Pediatric Pulmonary Vein Stenosis”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2018.01.029.

The American Journal of CardiologyJournal

Mechanism of Pulmonary Vein Stenosis in Infants with Normally Connected Veins

Sadr, Iran M, Puay E Tan, Mark W Kieran, and Kathy J Jenkins. 2000. “Mechanism of Pulmonary Vein Stenosis in Infants with Normally Connected Veins”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/s0002-9149(00)01022-5.

American Journal of Surgical PathologyJournal

Paucicellular Fibrointimal Proliferation Characterizes Pediatric Pulmonary Vein Stenosis

Kovach, Alexandra E., Philip M. Magcalas, Christina Ireland, Kerry McEnany, Andre M. Oliveira, Mark W. Kieran, Christopher W. Baird, Kathy Jenkins, and Sara O. Vargas. 2017. “Paucicellular Fibrointimal Proliferation Characterizes Pediatric Pulmonary Vein Stenosis”. American Journal of Surgical Pathology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pas.0000000000000892.

Catheterization and Cardiovascular InterventionsJournal