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NCT03822442 · ClinicalTrials.gov registry record

MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients

A clinical trial of Heart Failure and Congenital Heart Defects, sponsored by Children's National Research Institute.

Recruiting
Registry status
200
Enrollment target
1
Study location

NCT03822442 is a study of Heart Failure and Congenital Heart Defects that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 200 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03822442, a study of Heart Failure and Congenital Heart Defects, is actively recruiting participants, sponsored by Children's National Research Institute.

RECRUITING
Registry status
200 participants
Enrollment target
1
Study location

Study Summary

Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first to perform MR-guided cardiac catheterization in US children, and have accumulated the largest US experience, having performed over 75 procedures to date. Our unique experience puts us in strong position to leverage this technology to improve care of children with cardiomyopathy and transplant. Using an integrated approach, we will simultaneously (1) validate imaging measures of cardiac edema and fibrosis by correlating T1 and T2 map images with endomyocardial biopsy (EMB) results in Aim 1; (2) overlay T1, T2 map images into our x-ray system to display "hotspots" of T1 and T2 abnormalities to guide EMB in Aim 2; and (3) obtain radiation-free hemodynamic data in a highly vulnerable pediatric population by using CMR to guide catheter manipulation in the ICMR suite in Aim 3. Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.

Study Locations (1)

District of Columbia

  • Children's National Health System - Washington D.C.

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2019-12-10
Est. Completion 2026-12-31

What the Registry Record Tells You About NCT03822442

The ClinicalTrials.gov registry entry for NCT03822442 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 0 interventions.

NCT03822442 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03822442 about?

NCT03822442 is a clinical study titled "MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients". Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first t...

What is the current status of trial NCT03822442?

This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2019-12-10. Estimated completion is 2026-12-31.

What conditions does trial NCT03822442 study?

This clinical trial studies the following conditions: Heart Failure, Congenital Heart Defects, Cardiac Imaging Techniques.

Who is sponsoring clinical trial NCT03822442?

This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03822442 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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