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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Multidetector Computed Tomography; Pulmonary Embolism and Thrombosis; Hypertension Pulmonary Secondary

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Cesar Cristancho Rojas, physician; Phone Number: +525566119048; Email: cncr777@hotmail.com
• Study Contact Backup: Name: Tomas Pulido Zamudio, Doctor; Phone Number: +525554242597; Email: pulidot@me.com

Study Locations

• Mexico
  • Mexico City, Mexico
    • Recruiting
    • Instituto Nacional de Cardiologia Dr. Ignacio Chavez
    • Contact: Tomas Zamudio Pulido, Dr; Phone Number: +525551002561; Email: pulidot@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients from the pulmonary hypertension clinic at our institution, from July 2017 to October 2018

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Collaborators: Sergio Criales Vera; Mariana Díaz Zamudio; Nayeli Zayas Hernández; Eric Kimura Hayama; Regina De La Mora; Tomás Pulido Zamudio

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Multidetector Computed Tomography; Pulmonary Embolism; Hypertension Pulmonary Secondary
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Embolism; Thrombosis; Hypertension, Pulmonary; Pulmonary Embolism; Embolism and Thrombosis
• Other Study ID Numbers: PT-17-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: by request by mail

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No