Lung Perfusion Measured With Dual-Energy CT in Patients With Chronic Thromboembolic Pulmonary Hypertension: Comparative Study With Right Heart Catheterization and V/Q

Pulmonary Embolism and Thrombosis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03450304
• Other study ID #: PT-17-050
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2018
• Last updated: February 28, 2018
• Start date: September 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2018
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Cesar Cristancho Rojas, physician
• Phone: +525566119048
• Email: cncr777[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients from the pulmonary hypertension clinic at our institution who have had right heart catheterization and were referred for a pulmonary CT angiography as part of their imaging workup protocol.

Exclusion Criteria:

• creatinine > 1.5 mg/dL

Related Conditions & MeSH terms

• Embolism
• Embolism and Thrombosis
• Hypertension
• Hypertension Pulmonary Secondary
• Hypertension, Pulmonary
• Lung Neoplasms
• Multidetector Computed Tomography
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Thrombosis

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiología Dr. Ignacio Chávez	Mexico City

Sponsors (7)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez	Eric Kimura Hayama, Mariana Díaz Zamudio, Nayeli Zayas Hernández, Regina De La Mora, Sergio Criales Vera, Tomás Pulido Zamudio

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung perfusion measured with Dual-Energy CT (DECT) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)	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	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