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)

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03450304
Study type	Observational
Source	Instituto Nacional de Cardiologia Ignacio Chavez
Contact	Cesar Cristancho Rojas, physician
Phone	+525566119048
Email	cncr777@hotmail.com
Status	Recruiting
Phase	N/A
Start date	September 1, 2017
Completion date	December 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06348459` - Registry of Catheter Intervention in Pulmonary Embolism
Not yet recruiting	`NCT06232551` - Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism	N/A
Completed	`NCT03426124` - An International Pulmonary Embolism Registry Using EKOS
Not yet recruiting	`NCT06415968` - Prevalence and Characteristics of Intimate Partner Violence Against Individuals Seeking Hematological Consultations
Completed	`NCT02396758` - Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism	Phase 4
Recruiting	`NCT06051032` - Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy vs. Thromboaspiration.	N/A
Recruiting	`NCT05098769` - A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.
Enrolling by invitation	`NCT04855370` - Non-Invasive Measurement of Cardiac Output and Stroke Volume in PE	N/A
Recruiting	`NCT05482269` - Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography
Active, not recruiting	`NCT05481242` - An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients
Completed	`NCT04632641` - Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial	N/A
Recruiting	`NCT03101384` - Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism	N/A
Completed	`NCT04374617` - Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.