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NCT03688698 Clinical Trial

PET/MRI in PAH Patients

Pulmonary Arterial Hypertension Clinical Trial

Official title:
The Relationship Between Myocardial 18F-FDG Uptake and Right Ventricular Coupling Obtained by PET/MRI Hybrid Imaging in Patients With Pulmonary Arterial Hypertension.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03688698
Other study ID # 2017/25/N/NZ5/02689
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2016
Est. completion date January 1, 2018

Study information
Verified date September 2018
Source Medical University of Bialystok
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Aim of the study is to compare novel parameters of right ventricle (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG uptake.

Description:

Objectives In pilot study investigators aimed to compare novel parameters of right ventricle (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG uptake.

Background Right ventricular (RV) function is a major determinant of survival in patients with pulmonary arterial hypertension (PAH). Hemodynamic parameters like end-systolic elastance (Ees), arterial elastance (Ea), pulmonary arterial compliance (PAC) and Ees/Ea ratio have been shown to reflect RV function and prognosis in PAH. Increased RV 18F-fluoro-2-deoxyglucose (FDG) uptake in positron emission tomography (PET) was recently associated with progressive RV dysfunction in these patients.

Methods Twenty-five stable PAH patients (49.92±15.94 years) and twelve healthy subjects (control group, 44.75±13.51 years) had simultaneous PET and MRI scans performed. FDG was used as a tracer and its uptake was presented as a standardized uptake value (SUV) for both left (LV) and right ventricle.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date January 1, 2018
Est. primary completion date June 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- PAH

Exclusion Criteria:

The exclusion criteria were the following: patients in IV WHO class, Eisenmenger physiology, PAH associated with prevalent systemic-to-pulmonary shunts due to moderate to large defects (according to European guidelines) [16], group II, III, IV, V of pulmonary hypertension, diabetes mellitus and contraindications to cardiac MRI.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• PET/MRI
PET/MRI scans

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Bialystok

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in PET/MRI parameters in PAH Patients after 2 years follow-up in case of death or clinical deterioration We would like to depict most significant changes in newly approved parameters from hybrid PET/MRI imaging e.g. standardised uptake value of glucose in heart, right ventricle ejection fraction, end systolic elastance, mean pulmonary pressure. This could allow us indicate possible new prognostic factors in PAH. 2 years
Secondary Need of PAH targeted therapy escalation Clinical worsening of patient leading to therapy escalation. 2 years
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