Impact and Utility of PET Versus Clinical Score for the A... | NCT01532167

Studies
Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis

NCT01532167

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Status

Completed

Last Update Posted

Mar 27, 2012Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Takayasu Arteritis

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

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

Mar 2012

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

Feb 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Feb 8, 2012

First Submission Date that Met QC Criteria

Feb 13, 2012

First Posted Date

Feb 14, 2012Estimated

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

Mar 23, 2012

Last Update Posted Date

Mar 27, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose Telich, Investigator, Instituto Nacional de Cardiologia Ignacio ChavezPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cardiologia Ignacio ChavezOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to demonstrate that [18F]FDG PET is a a better method than clinical and laboratory values for the identification and assessment of inflammatory activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise evaluation of response to therapy.

Detailed Description

Inflammatory activity and fibrosis are the main causes of morbidity and mortality in patients with Takayasu arteritis. The investigators objective is to determine the utility of using 18F-FDG PET in the basal evaluation and follow-up of patients and compare the results with Dabague's clinical score.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

TA was diagnosed if the patient met 3 or more ACR criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated for TA at our institution's immunology outpatient clinic were included between.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria E Soto, MD	Instituto Nacional de Cardiologia	Principal Investigator
Erick Alexanderson, MD	Instituto Nacional de Cardiologia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Cardiologia		Mexico City	Mexico City		Mexico

Condition Browse Module

MeSH Terms

ID	Term
D013625	Takayasu Arteritis

Ancestor Terms

ID	Term
D001015	Aortic Arch Syndromes
D001018	Aortic Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided