Lung Perfusion Measured With Dual-Energy CT in Patients With Chronic Thromboembolic Pulmonary Hypertension: Comparative Study With Right Heart Catheterization and V/Q
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|ClinicalTrials.gov Identifier: NCT03450304|
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 2, 2018
A comparative, observational, cross-sectional and prolective diagnostic test study, including patients that have had a right heart catheterization and were referred for a CT pulmonary angiography as part of their imaging workup protocol for pulmonary hypertension.
Dual-energy computed tomography (DECT) pulmonary angiography was performed on each patient to obtain perfusion maps and do a quantitative analysis. Segments with and without perfusion defects according to significant differences in the quantitative values, were defined as compatible or not with chronic thromboembolism.
To assess the accuracy of the method and evaluate its performance, these results were compared with the sole results from the right heart catheterization, known to be the gold standard diagnostic tool.
|Condition or disease|
|Multidetector Computed Tomography Pulmonary Embolism and Thrombosis Hypertension Pulmonary Secondary|
a comparative, observational, cross-sectional and prolective diagnostic test study is conducted, including consecutive patients from the pulmonary hypertension clinic at our institution, from March 2017 to October 2018. Patients that have had a right heart catheterization and were referred for a CT pulmonary angiography as part of their imaging workup protocol. (The minimum sample size calculated is 26 patients).
DECT pulmonary angiography (256-slice and double-source CT scanner) was performed on each patient. Obtaining perfusion maps and doing a quantitative analysis by circular regions of interest (ROI) and iodine-related attenuation values (IRA) on each lung segment. Then, according to the finding in right heart catheterization, a comparison will be made between to groups: segments with and without perfusion defects, in order to find significant differences in the quantitative.
To assess the accuracy of the method and evaluate its performance, these results were later compared with the sole results from the right heart catheterization.
ROC curves were plotted to extract possible decision thresholds of the IRA values to classify perfusion as normal or deficient with this technique.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Lung Perfusion Measured With Dual-Energy CT (DECT) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH): Comparative Study With Right Heart Catheterization and Ventilation/Perfusion Scintigraphy (V/Q)|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
- Lung perfusion measured with Dual-Energy CT (DECT) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) [ Time Frame: cross-sectional (one measurement). The minimum sample size calculated is 26 patients, which with the amount of patients handled in the pulmonary hypertension clinic at our institution is expect to reach in 16 months or before through study completion ]The objective is to evaluate lung perfusion quantification by DECT in patients with Chronic Thromboembolic Pulmonary Hypertension and compare findings with digital subtraction angiography with right heart catheterization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450304
|Contact: Cesar Cristancho Rojas, firstname.lastname@example.org|
|Contact: Tomas Pulido Zamudio, Doctoremail@example.com|
|Instituto Nacional de Cardiología Dr. Ignacio Chávez||Recruiting|
|Mexico City, Mexico|
|Contact: Tomas Zamudio Pulido, Dr +525551002561 firstname.lastname@example.org|