Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575692
• Other study ID #: PH-06-CMR-01
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: May 27, 2014
• Start date: December 2006
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to identify changes in the cardiovascular system in patients with pulmonary hypertension (PH) by magnetic resonance imaging (MRI). MRI is accepted as golden standard method for the evaluation of left and right ventricular morphology and function.

All patients who showed elevated pulmonary pressure in the right heart catheter investigation are assigned to MRI. Parameters derived from MRI are included in the clinical and therapeutic decisions. Well established as well as new MRI parameters are evaluated and compared to the results of right heart catheter. Further age-matched controls without known cardiac or pulmonary disease are investigated by native MRI.

Description:

Patients with suspected, latent and manifest PH and controls are investigated by MRI according to the following protocol in breathhold or free breathing (depending on the patients' breath-hold abilities). In case of elevated Creatinin values, no contrast agent is applied.

• Planning of cardiac views: Planning of 2-chamber view, short axes view and 4-chamber view.

• Morphological overview: Transversal and coronal Haste images

• Left and right heart functional and valve evaluation: Cine 2-chamber imaging, Multi-slice cine 4-chamber imaging, Cine Left and Right ventricular outflow tract imaging and Multi-slice cine short axes imaging covering the left and right ventricle for evaluation of EDV, ESV, SV, EF, CO and muscle mass.

• Phase Contrast Imaging: Flow measurements in the aorta, the pulmonary artery and the heart.

• Perfusion measurement.

• Late enhancement measurement: Multi-slice short axes view, multi-slice 2-chamber view and multi-slice 4-chamber view.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Controls without history of cardiac or pulmonary diseases

• Patients with suspected PH

• Patients with latent PH

• Patients with manifest PH

Exclusion Criteria:

• MRI exclusion criteria

Study Design

N/A

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Late Enhancement Patterns
• MR Phase Contrast Velocity Imaging
• Pulmonary Hypertension
• Ventricular Function

Locations

Country	Name	City	State
Austria	Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology	Graz	Stmk.

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Reiter G, Reiter U, Kovacs G, Kainz B, Schmidt K, Maier R, Olschewski H, Rienmueller R. Magnetic resonance-derived 3-dimensional blood flow patterns in the main pulmonary artery as a marker of pulmonary hypertension and a measure of elevated mean pulmonar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	right ventricular function	right ventricular end-diastolic volume (EDV), right ventricular end-systolic volume (ESV), right ventricular stroke volume (SV), right ventricular ejection fraction (EF), right ventricular cardiac output (CO), right ventricular muscle mass (RVMM)	at the MRI investigation	No