Using capillaroscopy to improve diagnosis in patients with undifferentiated connective tissue disease
Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease: a Randomized Pilot Clinical Study
This study is testing if using a special microscope to look at tiny blood vessels can help doctors better diagnose and manage patients with undifferentiated connective tissue disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06399822 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled clinical trial aims to evaluate the impact of capillaroscopy on the management of patients diagnosed with undifferentiated connective tissue disease (UCTD). Conducted at the Quebec university hospital, the study will compare the outcomes of patients receiving capillaroscopy against those receiving usual care over a period of 12 months. The primary objective is to determine how capillaroscopy influences the diagnosis of better characterized connective tissue diseases within the first six months. Secondary objectives include assessing medication changes, healthcare utilization, and lifestyle modifications following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have been diagnosed with undifferentiated connective tissue disease and meet specific preliminary classification criteria.
Not a fit: Patients who have been diagnosed with a specific connective tissue disease or have previously undergone capillaroscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored treatments for patients with undifferentiated connective tissue disease.
How similar studies have performed: While capillaroscopy has been used in other contexts, this specific approach in managing UCTD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be aged 18 and over; * Have been diagnosed with undifferentiated connective tissue disease by a rheumatologist; * Meet the preliminary classification criteria for undifferentiated connective tissue disease: present signs and symptoms suggestive of connective tissue disease, but do not meet the criteria for a connective tissue disease and have a positive antinuclear antibody on at least 2 occasions; * Have developed the first signs and symptoms of the disease less than 10 years before recruitment. Exclusion Criteria: * In the opinion of the clinician, have a health condition that does not allow a delay of six months before carrying out the capillaroscopy; * Have been diagnosed and/or meet the classification criteria for another connective tissue disease (for example, systemic lupus, etc.); * Have already performed a capillaroscopy in the past, regardless of the time or the reason; * Be unable to consent or respond to questionnaires.
Where this trial is running
Québec, Quebec
- CHU de Quebec-Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Laetitia Michou, MD PhD — CHU de Quebec (Université Laval)
- Study coordinator: Laetitia Michou, MD PhD
- Email: laetitia.michou@crchudequebec.ulaval.ca
- Phone: 418-525-4444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.