Repeatability of OCT and IV-US in Pulmonary Arterial Hype... | NCT03105934

Studies
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension

NCT03105934

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Completed

Last Update Posted

Feb 12, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pulmonary Arterial Hypertension

Interventions

Patients with Pulmonary Arterial Hypertension

Countries

Spain

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Oct 18, 2017Actual

Completion Date

Jan 25, 2018Actual

First Submitted Date

Apr 4, 2017

First Submission Date that Met QC Criteria

Apr 4, 2017

First Posted Date

Apr 10, 2017Actual

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 9, 2018

Last Update Posted Date

Feb 12, 2018Actual

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

To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary Arterial Hypertension	Experimental	Patients with Pulmonary Arterial Hypertension	Procedure: Patients with Pulmonary Arterial Hypertension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with Pulmonary Arterial Hypertension	Procedure	2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.	Pulmonary Arterial Hypertension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Image measurements	Repeat acquisitions to be made in the same regions and in locations	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines

Exclusion Criteria:

That according to investigator criteria cannot participate in the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enric Domingo, MD	Hospital Vall d'Hebron	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Vall d'Hebron		Barcelona		08035	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C060424	hydralazine 4-anisaldehyde hydrazone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided