NCT02261870

Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2

"Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification. Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.

Conditions

• Acute Graft Rejection
• Heart Transplantation

Interventions

Type	Name	Description
DEVICE	MRI T2 quantification	MRI acquisitions will be performed according to the already described method based on conventional Fast Spin Echo sequences and with an additional calibration pad positioned on the patient thorax (dedicated pad made by the Nancy CIC-IT with stable and adapted T2). MRI will be performed if possible before the biopsy and otherwise the radiologist will be kept blinded of the biopsy results.

Timeline

• Start date: 2015-02-18
• Primary completion: 2020-02-27
• Completion: 2020-02-27
• First posted: 2014-10-10
• Last updated: 2020-05-12

Locations

10 sites across 1 country: France