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

Status

Unknown

Conditions

Multidetector Computed Tomography
Hypertension Pulmonary Secondary
Pulmonary Embolism and Thrombosis

Study type

Observational

Funder types

Other

Identifiers

NCT03450304
PT-17-050

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

There are currently no registered sites for this trial.

Central trial contact

Cesar Cristancho Rojas, physician; Tomas Pulido Zamudio, Doctor

Timeline

Last updated: Mar 02, 2018

Start date

Sep 01, 2017 • 7 years ago

End date

Sep 01, 2018 • 6 years ago

Today

Jan 21, 2025

Sponsor of this trial

Collaborating Sponsors

S

Sergio Criales Vera

T

Tomás Pulido Zamudio

N

Nayeli Zayas Hernández

R

Regina De La Mora

M

Mariana Díaz Zamudio

E

Eric Kimura Hayama

Data sourced from clinicaltrials.gov