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Premature Coronary Atherosclerosis in Scleroderma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372398
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
Tuen Mun Hospital

Tracking Information
First Submitted Date September 5, 2006
First Posted Date September 6, 2006
Last Update Posted Date September 16, 2010
Study Start Date October 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00372398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Premature Coronary Atherosclerosis in Scleroderma
Official Title Premature Coronary Atherosclerosis in Scleroderma: A Case Control Study
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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population scleroderma patients
Condition Scleroderma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 15, 2010)
28
Original Enrollment
 (submitted: September 5, 2006)
40
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age >= 18 years.
  2. Fulfillment of the American College of Rheumatology (ACR) criteria for the classification of scleroderma.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT00372398
Other Study ID Numbers NTWC/CREC/429/06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CC Mok, Tuen Mun Hospital, Hong Kong
Study Sponsor Tuen Mun Hospital
Collaborators Not Provided
Investigators
Principal Investigator: CC Mok, MD FRCP Tuen Mun Hospital, Hong Kong
PRS Account Tuen Mun Hospital
Verification Date September 2010