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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT04095351
Date of registration:	13/09/2019
Prospective Registration:	Yes
Primary sponsor:	Medical University Innsbruck
Public title:	Connective Tissue Diseases and Lung Manifestations Colipris
Scientific title:	Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)
Date of first enrolment:	December 9, 2019
Target sample size:	120
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT04095351
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Austria

Contacts

Name:	Graziella Plank
Address:
Telephone:
Email:
Affiliation:

Name:	Magdalena Aichner, MD
Address:
Telephone:	+43 512-504-83765
Email:	magdalena.aichner@i-med.ac.at
Affiliation:

Name:	Judith Löffler-Ragg, Prof. MD
Address:
Telephone:
Email:
Affiliation:	Medical University Innsbruck, Department Internal Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- The inclusion criteria are adult patients (=18 years) diagnosed with CTD with signed
informed consent.

Exclusion Criteria:

- Exclusion criteria are patients with a serious co-morbidity interfering with the
course of interstitial lung disease or pulmonary hypertension.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Connective Tissue Diseases

Interstitial Lung Disease

Systemic Sclerosis

Intervention(s)

Biological: Blood sampling

Diagnostic Test: Imaging

Diagnostic Test: Pulmonary function test

Primary Outcome(s)

Decline in Diffusion capacity for carbon monoxide [Time Frame: 1 year]

Increase in the modified Rodnan Skin Score [Time Frame: 1 year]

Decline in forced vital capacity [Time Frame: 1 year]

Secondary Outcome(s)

Secondary ID(s)

20190506-2003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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