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NCT05521399 · ClinicalTrials.gov registry record

Heart Transplantation - Renewal

A clinical trial of Magnetic Resonance Imaging and Transplant, Heart, sponsored by Northwestern University.

Recruiting
Registry status
247
Enrollment target
2
Study locations

NCT05521399 is a study of Magnetic Resonance Imaging and Transplant, Heart that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 247 participants, above the 146-participant average among 20 other Magnetic Resonance Imaging trials with a reported enrollment target (69% higher). The trial reports 2 study locations across 1 state.

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The verdict

NCT05521399, a study of Magnetic Resonance Imaging and Transplant, Heart, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
247 participants
Enrollment target
2
Study locations

Study Summary

Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Current standard clinical tests, however, rely on frequent invasive procedures including endomyocardial biopsies (EMB) and catheter angiography (Cath). In addition, these standard tests are limited by sampling error, the diffuse nature of HTx complications, and high health care utilization cost, estimated at \>$150,000 per year per patient in the US. To address these limitations, our group has developed a non-invasive multiparametric cardiac MRI, which can quantify abnormal changes in heart tissue and function. Our efforts during the initial period of this study (NIH funded 2014-2019) have focused on the two major complications of HTx: 1) acute cardiac rejection (ACR), the leading cause of death in the first year after heart transplant; and 2) cardiac allograft vasculopathy (CAV), the greatest risk factor for 5-year mortality beyond the first year after heart transplantation. For these major compilation, our previous cardiac MRI studies have identified new non-invasive cardiac MRI measures that can detect abnormalities of heart tissue and function. In addition, the data was able to show that heart donor and recipient mismatch (age, sex, height, weight, etc.) can cause changes in tissue and function of the transplanted heart.

Interventions

  • DIAGNOSTIC_TEST MRI Sequencing
  • DIAGNOSTIC_TEST MRI Testing (pediatric)
  • DIAGNOSTIC_TEST MRI Testing

Study Locations (2)

Illinois

  • Northwestern University- Feinberg School of Medicine - Chicago
  • The Ann & Robert Lurie Children's Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2021-11-19
Est. Completion 2030-01-31

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT05521399

The ClinicalTrials.gov registry entry for NCT05521399 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 146-participant average among 20 other Magnetic Resonance Imaging trials with a reported enrollment target (69% higher). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Magnetic Resonance Imaging appearing as the primary indexed condition, and to 3 interventions - of which MRI Sequencing is the first listed.

NCT05521399 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT05521399 about?

NCT05521399 is a clinical study titled "Heart Transplantation - Renewal". Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Current standard clinical tests, however, rely on frequent invasive...

What is the current status of trial NCT05521399?

This trial is currently recruiting. The enrollment target is 247 participants. The study started on 2021-11-19. Estimated completion is 2030-01-31.

What conditions does trial NCT05521399 study?

This clinical trial studies the following conditions: Magnetic Resonance Imaging, Transplant, Heart.

What interventions are being tested in trial NCT05521399?

The interventions under investigation include: MRI Sequencing (DIAGNOSTIC_TEST), MRI Testing (pediatric) (DIAGNOSTIC_TEST), MRI Testing (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05521399?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05521399 being conducted?

This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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