Quantification of diseases in small vessels of the human myocardium - a new approach in quantificatio

Phase 1

• Conditions: Patients with cardiovascular diseases and suspect of myocardial microvasculopathy; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003234-32-DE
• Lead Sponsor: niversitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-24
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 125

Inclusion Criteria

- cardiac disease with suspected microvasculopathy (hypertension, chronic myocardial infarction, hypertrophic cardiomyopathy, post-heart transplantation, cardiac dystrophinopathy)
- age >18 years
- ability to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- contraindications to magnetic resonance imaging
- contraindications to Feraheme or Magnevist
- asthma / allergic predisposition
- pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that pathological changes in the myocardial microvasculature can be detected and measured by cardiovascular magnetic resonance imaging following the application of Feraheme and special T2-mapping sequences;Secondary Objective: To demonstrate that this novel approach is superior to the established T1-mapping technique;Primary end point(s): To demonstrate that the intravascular volume in the myocardium can be measured non-invasively by cardiovascular magnetic resonance imaging following the application of Feraheme and special T2-mapping sequences;Timepoint(s) of evaluation of this end point: 12h to 24h after infusion of Feraheme

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To demonstrate that this novel approach based on T2-mapping following infusion of Feraheme is superior to T1-mapping following infusion of Magnevist;Timepoint(s) of evaluation of this end point: 12h to 24h after infusion of Feraheme