NCT00843102

Brief Summary

Aim: Determination of frequency and nature of coronary involvement (including epicardial and microvascular) among scleroderma patients referred for right heart catheterization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

February 12, 2009

Last Update Submit

June 12, 2012

Conditions

Systemic Sclerosis

Keywords

atherosclerosispulmonary hypertension

Outcome Measures

Primary Outcomes (2)

  • Occurrence of angiography proven coronary disease

    1 year

  • Occurence of pulmonary arterial hypertension

    1 year

Secondary Outcomes (1)

  • Overall mortality

    5 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Systemic sclerosis

You may qualify if:

  • patients with rheumatologist established systemic sclerosis
  • informed consent

You may not qualify if:

  • left ventricular ejection fraction \<30%
  • severly (\<60% of predicted) deteriorated pulmonary function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs, Hungary

Pécs, H-7623, Hungary

Location

Related Publications (2)

  • Komocsi A, Pinter T, Faludi R, Magyari B, Bozo J, Kumanovics G, Minier T, Radics J, Czirjak L. Overlap of coronary disease and pulmonary arterial hypertension in systemic sclerosis. Ann Rheum Dis. 2010 Jan;69(1):202-5. doi: 10.1136/ard.2008.096255.

    PMID: 19158116RESULT

  • Kolto G, Faludi R, Aradi D, Bartos B, Kumanovics G, Minier T, Czirjak L, Komocsi A. Impact of cardiac involvement on the risk of mortality among patients with systemic sclerosis: a 5-year follow-up of a single-center cohort. Clin Rheumatol. 2014 Feb;33(2):197-205. doi: 10.1007/s10067-013-2358-4. Epub 2013 Aug 14.

    PMID: 23942767DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Scleroderma, SystemicAtherosclerosisHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesHypertension

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior lecturer

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

May 1, 2012

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

HU(1)