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Right Ventricular and Pulmonary Artery Evaluation by CMR

NCT ID: NCT03377673

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2018-11-01

Brief Summary

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Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance derived RV ejection fraction is a prognostic value in this condition.

Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and size may be evaluated by cardiac magnetic resonance imaging and could have great importance in evaluation of pulmonary hypertension prognosis and outcomes.

Detailed Description

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Pulmonary hypertension is defined as an increase in mean pulmonary artery pressure \> 25 mmHg evaluated by right heart catheterisation. Over time increased pulmonary artery pressure eventually causes vascular remodelling and right ventricular dysfunction. The right and left ventricles interact sharing a common pericardial sac and interventricular septum. Frequently right ventricle dysfunction reflects clinical PH worsening.

The aim of this study was to assess the geometry, function and morphology of right ventricle and also pulmonary artery diameter and stiffness in pulmonary hypertension patients by cardiovascular magnetic resonance.

Patients are recruited from the Hospital of Lithuanian University of Health Sciences Kaunas clinics Pulmonary hypertension center.

Study inclusion criteria:

1. Patient with diagnosed pulmonary hypertension
2. RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
3. Patients who signed study informed consent form.

Study exclusion criteria:

1. Coronary and valvular heart disease
2. Atrial fibrillation
3. Expressed shortness of breath
4. Claustrophobia.

Suspected number of participants - 100.

Data Analysis Statistical analyses will be performed using SPSS 22.0 package (SPSS, Chicago, IL, USA). Continuous variables will be expressed as mean +/- standard deviation, skewed variables as median (interquartile range). Chi square test will be used for qualitative parameters. For continuous variables, differences between two groups will be compared using non-parametric Mann-Whitney U test. Relation between variables will be assessed using Spearman correlation coefficient. Univariate analysis of predictors for survival will be used. In order to assess minimally false negative and minimally false positive results with greatest accuracy, the method of ROC (Receiver Operating Characteristics) curve will be used. The optimal values will be separated out the different groups (survival/non-survival) with the highest accuracy (minimal false negative and false positive). Survival curves will be established by the Kaplan-Meier estimation method. Cox regression analysis will be used to identify independent predictor of outcomes. Two-tailed probability values at p\<0,05 will be considered statistically significant.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CMR

CMR is performed using a 1,5T whole-body system (Siemens Aera, Siemens Medical Solutions; Erlangen, Germany)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patient with diagnosed pulmonary hypertension
2. RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
3. Patients who signed study informed consent form.

Exclusion Criteria

1. Coronary and valvular heart disease
2. Atrial fibrillation
3. Expressed shortness of breath
4. Claustrophobia.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Egle Ereminiene

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lina Padervinskiene, PhD

Role: STUDY_DIRECTOR

LSMU

Locations

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LSMU

Kaunas, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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no. BE-2-23

Identifier Type: -

Identifier Source: org_study_id