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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: Recruiting study of Magnetic Resonance Imaging and Transplant, Heart, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Long-term Follow-Up (\> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by the number of acute rejection (ACR) episodes, ACR grade (1R, 2R, 3R)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2021-11-19 |
| Est. Completion | 2030-01-31 |
What NCT05521399 shows while recruiting
NCT05521399 is an observational study that tracks outcomes without assigning an intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 146-participant average among 20 other Magnetic Resonance Imaging trials with a reported enrollment target (69% higher).
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 a single indexed study location in 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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Where NCT05521399's enrollment target sits among peer trials
247 4th of 20 higher than 17 of 20 other Magnetic Resonance Imaging trials
participants (enrollment target), bucketed by value
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