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Trial record 9 of 31 for:    Recruiting, Active, not recruiting, Enrolling by invitation Studies | Pulmonary Hypertension | Canada

A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis

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: NCT03889509
Recruitment Status : Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Janet Pope, Lawson Health Research Institute

Tracking Information
First Submitted Date March 22, 2019
First Posted Date March 26, 2019
Last Update Posted Date March 26, 2019
Actual Study Start Date March 1, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 22, 2019)
  • Prevalence of Pulmonary arterial hypertension in scleroderma [ Time Frame: 2 years from study start date ]
    to determine the prevalence associated with pulmonary arterial hypertension in scleroderma
  • Risk factors for pulmonary arterial hypertension in scleroderma [ Time Frame: 2 years from study start date ]
    to determine the risk factors associated with pulmonary arterial hypertension in scleroderma
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis
Official Title A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis
Brief Summary This protocol is of a systematic review for risk factors of pulmonary arterial hypertension in systemic sclerosis.
Detailed Description

A systematic review was conducted to determine the risk/associated factors for pulmonary arterial hypertension in systemic sclerosis, including clinical/disease characteristics, antibody status, test results and biomarkers. The frequency of publications featuring a risk/association were reported. The following databases were searched: Medline, EMBASE, the Cochrane Library, Web of Science, and SCOPUS.

The following search terms were used:

( essential pulmonary hypertension or familial primary pulmonary hypertension or hypertension, pulmonary or hypertension,lung or hypertensive pulmonary vascular disease or idiopathic pulmonary arterial hypertension or lung arterial hypertension or lung artery hypertension or lung hypertension or primary pulmonary hypertension or pulmonary arterial hypertension or pulmonary artery hypertension or pulmonary fixed hypertension or pulmonary hypertensive disease or pulmonary hypertensive diseases or pulmonary hypertensive disorder or pulmonary hypertensive disorders )

AND

( generalised scleroderma or generalized scleroderma or progressive scleroderma or progressive sclerodermia or progressive sclerosis,systemic or progressive systemic sclerosis or scleroderma, generalised or scleroderma, generalized or scleroderma, progressive or scleroderma, systemic or sclerosis,progressive systemic or sclerosis,systemic or sclerosis,systemic progressive or systemic progressive sclerosis or systemic scleroderma or systemic sclerosis,progressive or

scleroderma, limited or limited scleroderma or limited cutaneous scleroderma or

diffuse scleroderma or progressive diffuse scleroderma or scleroderma, diffuse )

AND

( prevalence or prevalence study or relative risk or risk factors )

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study reflects a search strategy of available literature on pulmonary arterial hypertension in scleroderma.
Condition
  • Pulmonary Arterial Hypertension
  • Systemic Sclerosis
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 Active, not recruiting
Actual Enrollment
 (submitted: March 22, 2019)
63
Original Actual Enrollment Same as current
Estimated Study Completion Date March 1, 2021
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Studies were included they were (1) in patients with SSc; and if they (2) determined PAH with right heart catheterization; (3) involved a comparison of SSc patients with and without PAH; and (4) had sample size larger than 20.

Exclusion Criteria:

  • Studies were excluded if they were review articles, and if the study was written in languages other than English. When the same patients were used in more than one analysis, the most recent or largest sample-size study was included.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03889509
Other Study ID Numbers YJJEP0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Janet Pope, Lawson Health Research Institute
Study Sponsor Lawson Health Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Janet E Pope, MD MPH St. Joseph's healthcare London
PRS Account Lawson Health Research Institute
Verification Date March 2019