Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.

Cardiac MRI Clinical Trial

— IRM Cardiaque  

Official title:

Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103852
• Other study ID #: 2017-A03145-48
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: December 13, 2021

Study information

• Verified date: October 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old

• Having an indication for a diagnostic of right cardiac catheterization at the J Cartier Hospital for one of the following pathologies: dilated, restrictive cardiomyopathy, pulmonary arterial hypertension, chronic constrictive pericarditis, chronic post-embolic pulmonary heart.

• Subject affiliated or beneficiary of a social security scheme

• Patient having freely signed the informed consent.

Exclusion Criteria:

• Pregnancy (declarative, known pregnancy, any unexplained period delay in a woman of childbearing age)

• Presence of a contraindication to MRI: intraocular metallic splinter, surgical clip for cerebral aneurysm, claustrophobia, defibrillator, implanted electronic equipment) or to gadolinium chelates (anaphylactic reactions to gadolinium chelates, creatinine clearance <= 30 ml / min).

• Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.

• Patient participating in another clinical study

Related Conditions & MeSH terms

• Cardiac MRI

Intervention

Procedure:
• Cardiac MRI
vigilant patient installed in the MRI with compatible ECG electrodes for synchronization and monitoring, blood pressure cuff for monitoring, cardiac antenna. Sterile drape over the femoral region, femoral local anesthesia, femoral venipuncture, Swan Ganz probe venous navigation (CE marking, MRI compatible at 1.5T) with balloon inflated with 2 cc of gadolinium, navigation under real time SSFP cine sequence.

Locations

Country	Name	City	State
France	Hôpital Jacques Cartier	Massy

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation	Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation, as well as all the anatomical, functional, flow and substrate determination data by magnetic resonance (N / 35,%).	24 hours