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NCT05241418 · ClinicalTrials.gov registry record
Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease
A clinical trial of Congenital Heart Disease and Fibrosis Myocardial, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT05241418: Recruiting study of Congenital Heart Disease and Fibrosis Myocardial, sponsored by Boston Children's Hospital.
NCT05241418 is a study of Congenital Heart Disease and Fibrosis Myocardial that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 50 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05241418, a study of Congenital Heart Disease and Fibrosis Myocardial, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.
Primary Outcome
Atrial 3D-LGE-CMR images will be post-processed using the Circle ADAS 3D software module (Circle Cardiovascular Inc., Calgary, AB, Canada) and analyzed to identify fibrotic tissue. Results are portrayed as 3D-colored maps and as a calculated percentage of atrial fibrosis relative to total atrial surface area. All CMR images will be analyzed by two observers for the calculation of interrater reliability of the percent of atrial LGE. One observer will perform contours twice for the purposes of int
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Atrial 3D late gadolinium enhancement
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-03-23 |
| Est. Completion | 2029-06-30 |
What NCT05241418 shows while recruiting
NCT05241418 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Atrial 3D late gadolinium enhancement is the first listed.
NCT05241418 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05241418 about?
NCT05241418 is a clinical study titled "Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease". In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysio...
What is the current status of trial NCT05241418?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2022-03-23. Estimated completion is 2029-06-30.
What conditions does trial NCT05241418 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Fibrosis Myocardial, Fibrosis; Heart.
What interventions are being tested in trial NCT05241418?
The interventions under investigation include: Atrial 3D late gadolinium enhancement (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05241418?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05241418 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05241418's enrollment target sits among peer trials
50 41st of 63 higher than 18 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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