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Trial record 15 of 33 for:    CTEPH | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Collaborators:
Sergio Criales Vera
Mariana Díaz Zamudio
Nayeli Zayas Hernández
Eric Kimura Hayama
Regina De La Mora
Tomás Pulido Zamudio
Information provided by (Responsible Party):
César Cristancho rojas, Instituto Nacional de Cardiologia Ignacio Chavez

Brief 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.


Condition or disease
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
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients from the pulmonary hypertension clinic at our institution, from July 2017 to October 2018
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Cesar Cristancho Rojas, physician +525566119048 cncr777@hotmail.com
Contact: Tomas Pulido Zamudio, Doctor +525554242597 pulidot@me.com

Locations
Mexico
Instituto Nacional de Cardiología Dr. Ignacio Chávez Recruiting
Mexico City, Mexico
Contact: Tomas Zamudio Pulido, Dr    +525551002561    pulidot@me.com   
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Sergio Criales Vera
Mariana Díaz Zamudio
Nayeli Zayas Hernández
Eric Kimura Hayama
Regina De La Mora
Tomás Pulido Zamudio

Responsible Party: César Cristancho rojas, Resident, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT03450304     History of Changes
Other Study ID Numbers: PT-17-050
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: by request by mail

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by César Cristancho rojas, Instituto Nacional de Cardiologia Ignacio Chavez:
Multidetector Computed Tomography
Pulmonary Embolism
Hypertension Pulmonary Secondary

Additional relevant MeSH terms:
Hypertension
Thrombosis
Hypertension, Pulmonary
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Lung Neoplasms
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms