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

NCT03450304 | Unknown

• 1 other identifier: PT-17-050
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multidetector Computed Tomography; Pulmonary Embolism and Thrombosis; Hypertension Pulmonary Secondary

Keywords

Multidetector Computed Tomography; Pulmonary Embolism; Hypertension Pulmonary Secondary

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• creatinine \> 1.5 mg/dL

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Cardiología Dr. Ignacio Chávez

Mexico City, Mexico

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Cesar Cristancho Rojas, physician

CONTACT

+525566119048; cncr777@hotmail.com

Tomas Pulido Zamudio, Doctor

CONTACT

+525554242597; pulidot@me.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 1, 2018
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)