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PET/MRI in PAH Patients

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ClinicalTrials.gov Identifier: NCT03688698
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Remigiusz Kazimierczyk, Medical University of Bialystok

Brief 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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Radiation: PET/MRI

Detailed 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 37 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
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.
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : January 1, 2018


Group/Cohort Intervention/treatment
PAH Radiation: PET/MRI
PET/MRI scans

Controls Radiation: PET/MRI
PET/MRI scans




Primary Outcome Measures :
  1. Changes in PET/MRI parameters in PAH Patients after 2 years follow-up in case of death or clinical deterioration [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Need of PAH targeted therapy escalation [ Time Frame: 2 years ]
    Clinical worsening of patient leading to therapy escalation.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We enrolled twenty-five stable adult patients diagnosed with pulmonary arterial hypertension. A diagnosis of pre-capillary pulmonary hypertension (PH) was confirmed by right heart catheterization [mean pulmonary artery pressure (mPAP) ≥25 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg] and the use of an algorithm that included perfusion lung scan, echocardiography, respiratory function tests, and computer tomography to rule out secondary PH causes according to European guidelines [16]. The control group consisted of twelve healthy controls who were matched based on sex and age. During the baseline evaluation, we performed a physical examination, six-minute walk test, laboratory tests e.g. serum B-type natriuretic peptide (BNP), morphology and renal function parameters.
Criteria

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.

Additional Information:

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Responsible Party: Remigiusz Kazimierczyk, MD, PhD Student, Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03688698    
Other Study ID Numbers: 2017/25/N/NZ5/02689
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases