Premature Coronary Atherosclerosis in Scleroderma | NCT00372398

Studies
Premature Coronary Atherosclerosis in Scleroderma

NCT00372398

Sponsor

Tuen Mun Hospital

Status

Completed

Last Update Posted

Sep 16, 2010Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Scleroderma

Interventions

Not provided

Countries

Hong Kong

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

Sep 2010

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

Oct 2006

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 5, 2006

First Submission Date that Met QC Criteria

Sep 5, 2006

First Posted Date

Sep 6, 2006Estimated

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

Sep 15, 2010

Last Update Posted Date

Sep 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls.

Detailed Description

Coronary calcium scores will be obtained from a group of patients with scleroderma and a group of controls. Comparison of the calcium scores will be made.

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

28Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years.
Fulfillment of the American College of Rheumatology (ACR) criteria for the classification of scleroderma.

Accepts Healthy Volunteers

Yes

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

scleroderma patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CC Mok, MD FRCP	Tuen Mun Hospital Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuen Mun Hospital		Hong Kong			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse
D012598	Sclerosis
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided