Lung Perfusion Measured With Dual-Energy CT in Patients W... | NCT03450304

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

NCT03450304

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Status

Unknown status

Last Update Posted

Mar 2, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Multidetector Computed Tomography
Pulmonary Embolism and Thrombosis
Hypertension Pulmonary Secondary

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Feb 22, 2018

First Submission Date that Met QC Criteria

Feb 27, 2018

First Posted Date

Mar 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2018

Last Update Posted Date

Mar 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

César Cristancho rojas, Resident, Instituto Nacional de Cardiologia Ignacio ChavezPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cardiologia Ignacio ChavezOTHER

Collaborators

Name	Class
Sergio Criales Vera	UNKNOWN
Mariana Díaz Zamudio	UNKNOWN
Nayeli Zayas Hernández	UNKNOWN
Eric Kimura Hayama

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cesar Cristancho Rojas, physician	Contact	+525566119048		cncr777@hotmail.com
Tomas Pulido Zamudio, Doctor	Contact	+525554242597		pulidot@me.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Cardiología Dr. Ignacio Chávez	Recruiting	Mexico City			Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

by request by mail

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

César Cristancho rojas, Resident, Instituto Nacional de Cardiologia Ignacio Chavez

Unposted Events

Type	Date	Date Unknown
Release	Sep 16, 2019
Reset	Oct 4, 2019
Release	Oct 27, 2019

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Sep 16, 2019

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 16, 2019			Oct 4, 2019
Oct 27, 2019			Nov 14, 2019
Nov 25, 2019			Dec 12, 2019
Dec 12, 2019			Dec 31, 2019

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases