Capillaroscopy for Connective Tissue Disease

Overseen By William Berthelot, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Other CTD, Prior capillaroscopy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of nail capillaroscopy, a quick and painless test, to better understand and diagnose connective tissue diseases (CTD), particularly in individuals with undifferentiated connective tissue disease (UCTD). The researchers aim to determine if conducting this test earlier improves the accuracy of CTD identification. Participants will be divided into two groups: one will receive the test shortly after joining, while the other will have it six months later. Eligible participants have received a UCTD diagnosis from a doctor and exhibit signs and symptoms of CTD without a definite diagnosis. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance early diagnosis of CTD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that capillaroscopy is safe for patients with connective tissue disease?

Research has shown that nailfold capillaroscopy is a safe and well-known test. Studies have found it reliable for examining tiny blood vessels in the skin. This non-invasive method does not involve breaking the skin or causing pain. It is often used to assess blood flow changes in diseases affecting connective tissues.

Participants who have undergone this test have not reported any serious side effects. It is considered low-risk, with no major negative effects linked to it. In summary, nailfold capillaroscopy is generally safe and well-tolerated in its current use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nail capillaroscopy for connective tissue diseases because it offers a non-invasive method to observe microcirculation changes early on. Unlike traditional methods that might require more invasive procedures to assess disease progression, capillaroscopy allows doctors to directly visualize small blood vessels in the nail bed, potentially leading to quicker diagnosis and treatment adjustments. This technique could help catch disease-related changes much earlier than current options, paving the way for more timely interventions.

What evidence suggests that capillaroscopy is effective for diagnosing connective tissue diseases?

Research has shown that examining the tiny blood vessels near the base of fingernails, a process called nailfold capillaroscopy, can help diagnose connective tissue diseases like systemic sclerosis. It also aids in assessing related issues such as high blood pressure in the lungs. Studies have found that many people with these diseases exhibit unusual results in this test, which are linked to other health problems like lung issues. This test helps identify damage to small blood vessels in these conditions. For those with undifferentiated connective tissue disease, unusual test results might indicate a higher risk of developing a more specific disease over time. Therefore, this test could be useful in identifying people at risk of their disease worsening. Participants in this trial will be divided into two groups: one group will undergo capillaroscopy shortly after recruitment, while the control group will have the test performed six months later. ^{3 6 7 8 9}

Who Is on the Research Team?

Laetitia Michou, MD PhD

Principal Investigator

CHU de Quebec (Université Laval)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with signs of connective tissue disease but not fully meeting the criteria for a specific one. They must have had symptoms for less than 10 years and be diagnosed with undifferentiated connective tissue disease by a rheumatologist.

Inclusion Criteria

I have been diagnosed with a rare connective tissue disease by a specialist.

My first symptoms appeared less than 10 years ago.

I show signs of a connective tissue disease but don't fully meet the diagnosis criteria, and I have tested positive for antinuclear antibodies twice.

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

I have been diagnosed with a connective tissue disease like lupus.

I am unable to give consent or answer questions due to my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Assessment

Participants are randomized into two groups and undergo initial assessments

1 month

1 visit (in-person)

Capillaroscopy Intervention

Capillaroscopy is performed for the intervention group within one month of recruitment and for the control group at six months

6 months

1 visit (in-person) for capillaroscopy

Follow-up

Participants are monitored for changes in diagnosis, medication, and lifestyle factors

12 months

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Nail Capillaroscopy

Trial Overview The study tests if nail capillaroscopy, a non-invasive diagnostic tool, can help in managing undifferentiated connective tissue diseases by identifying those at risk of developing more defined conditions like Systemic sclerosis.

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 Intervention

In the control group, the capillaroscopy will be performed six months (+/- 2 weeks) after recruitment.

Group II: Capillaroscopy Active Control 1 Intervention

In the capillaroscopy group, the capillaroscopy will be performed in the month following recruitment.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Published Research Related to This Trial

Nailfold capillaroscopy (NFC) is increasingly recognized for its usefulness in rheumatology, particularly in assessing microvascular changes in noninfectious vasculitides, although it has been underexplored in this area.

This systematic review aims to summarize the key NFC changes observed in vasculitis, highlight the clinical significance of these findings, and identify potential future research directions to enhance its application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current role of capillaroscopy in vasculitides. Bertolazzi, C., Gallegos-Nava, S., Villarreal-Treviño, AV., et al.[2020]

In a study of 530 patients who underwent nailfold capillaroscopy (NC), only 3.8% had a change in diagnosis after the procedure, indicating that while NC is useful, its impact on diagnosing connective tissue diseases is limited.

The presence of positive antinuclear antibodies was linked to a higher likelihood of abnormal NC patterns, suggesting that autoantibody testing can help predict NC results and potential diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of nailfold capillaroscopy in daily clinical practice. Torrens Cid, LA., Soleto K, CY., Montoro-Álvarez, M., et al.[2021]

In a study of 120 healthy individuals aged 18 to 70, 67% exhibited morphological changes in nailfold capillaries, indicating that such changes are common and should not be immediately considered abnormal.

A new scoring system was developed to assess capillary changes, suggesting that while alterations are frequent, they are normal unless they exceed a certain threshold, which could indicate potential health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative and quantitative assessment of nailfold capillaries by capillaroscopy in healthy volunteers. Hoerth, C., Kundi, M., Katzenschlager, R., et al.[2012]

In a study of 49 juvenile systemic lupus erythematosus (JSLE) patients, nailfold capillaroscopy (NFC) revealed abnormal changes in over half of the patients, indicating its effectiveness in detecting microangiopathy associated with SLE.

A significant correlation was found between a branched pattern in NFC and central nervous system (CNS) involvement, suggesting that these capillary changes could influence treatment strategies for patients with CNS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Comparison of Nailfold Capillaroscopy between Juvenile Systemic Lupus Erythematosus and Healthy Controls: Correlation with Laboratory and Clinical Parameters. Raeeskarami, SR., Namazi, N., Assari, R., et al.[2022]

Nailfold capillaroscopy (NFC) findings in patients with systemic sclerosis (SS) and systemic lupus erythematosus (SLE) can reflect disease severity and changes over time, making it a valuable prognostic tool in these connective tissue disorders.

In a study of 43 patients over 20 months, significant clinical improvement was observed in 90.9% of cases with improved NFC findings, compared to only 47.8% in those without changes in NFC, highlighting the importance of NFC in monitoring disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nailfold capillaroscopy as a prognostic marker for connective tissue diseases: An observational clinico-epidemiological study. Abhijit Desai, S., Nayak, CS.[2023]

In a study of 123 patients with systemic lupus erythematosus (SLE), nailfold capillaroscopy (NFC) revealed significant capillary abnormalities in 35.8% of cases, indicating its potential as a diagnostic tool for assessing microvascular changes in SLE.

The severity of capillary abnormalities was strongly correlated with the SLEDAI index, suggesting that NFC findings may reflect a more severe clinical course of the disease, particularly in patients with positive anti-U1-RNP antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of nailfold videocapillaroscopic abnormalities in patients with systemic lupus erythematosus. Ingegnoli, F., Zeni, S., Meani, L., et al.[2019]

In a study of 60 patients with connective tissue disease and Raynaud's phenomenon, those with systemic sclerosis (SSc) showed significant changes in nailfold capillaries, including fewer capillary loops and larger capillary diameters compared to non-SSc patients.

Nailfold video-capillaroscopy (NVC) demonstrated diagnostic value for SSc, with specific capillary characteristics (like giant capillaries and severe effusion) providing high sensitivity and specificity for distinguishing SSc from other connective tissue diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diagnostic significance of nailfold video-capillaroscopy in systemic sclerosis]. Li, LG., Zhang, JL., Liu, XH., et al.[2014]

Nailfold video capillaroscopy (NVC) is the gold standard for assessing microvascular changes in systemic sclerosis (SSc), but alternative devices like dermatoscopy and smartphone attachments can provide useful insights, with dermatoscopy showing a higher percentage of interpretable and classifiable images compared to NVC.

While dermatoscopy is more portable and affordable, it has lower sensitivity than NVC, making it a potential screening tool that requires confirmation by NVC for accurate diagnosis of SSc.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods of Assessing Nailfold Capillaroscopy Compared to Video Capillaroscopy in Patients with Systemic Sclerosis-A Critical Review of the Literature. Ma, Z., Mulder, DJ., Gniadecki, R., et al.[2023]

This study evaluated nailfold capillary characteristics in 150 healthy individuals aged 20 to 60, revealing common morphological features like tortuous (45.33%) and meandering (44.66%) capillaries, which can help establish a baseline for normal capillary structure.

The research found that individuals with a BMI over 25 had significantly decreased visibility of capillary plexus, and older individuals (over 40 years) showed increased tortuous and receding capillaries, suggesting that these factors may influence capillary morphology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nailfold Capillaroscopy of Healthy Individuals - An Observational Study. Gorasiya, AR., Mehta, HH., Prakashey, A., et al.[2022]

A new image enhancement technique for nailfold capillaroscopy significantly improved the visual quality of images, with most observers preferring the enhanced images for assessing capillary networks.

The reliability of measurements increased, as indicated by a rise in the intra-class correlation coefficient from 0.76-0.84 to 0.82-0.89, suggesting that enhanced images allow for more accurate and efficient evaluations of capillary details in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image enhancement effect on inter and intra-observer reliability of nailfold capillary assessment. Karbalaie, A., Etehadtavakol, M., Abtahi, F., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10341321/

Methods of Assessing Nailfold Capillaroscopy Compared ... Introduction: Nailfolds of patients with systemic sclerosis (SSc) provide an opportunity to directly visualize microvascular remodeling in SSc.

2. nature.com nature.com/articles/s41598-025-92093-7

Alterations in nailfold videocapillaroscopy among patients ... This study examines the correlation between nailfold videocapillaroscopy (NVC) abnormalities and pulmonary hypertension (PH) in connective tissue disease (CTD) ...

3. jrheum.org jrheum.org/content/early/2018/12/10/jrheum.180615

Abnormal Nailfold Capillaroscopy Is Common in Patients ... Abnormal Nailfold Capillaroscopy Is Common in Patients with Connective Tissue Disease and Associated with Abnormal Pulmonary Function Tests.

4. rmdopen.bmj.com rmdopen.bmj.com/content/9/3/e003071

Microvascular damage in autoimmune connective tissue ... Nailfold videocapillaroscopy (NVC) allows the detection of microvascular damage in autoimmune connective tissue diseases (CTDs).

5. ijdvl.com ijdvl.com/nailfold-capillaroscopy-as-a-prognostic-marker-for-connective-tissue-diseases-an-observational-clinico-epidemiological-study/

Nailfold capillaroscopy as a prognostic marker for ... Nailfold capillaroscopy (NFC) is useful in the diagnosis and assessment of various connective tissue diseases. In this study, NFC findings were ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1521694223000359

Nailfold capillaroscopy Nailfold capillaroscopy is a safe and well-established method for the assessment of structural alterations of the microcirculation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8573234/

Nailfold capillaroscopy by smartphone-dermatoscope for ... Nailfold capillaroscopy by smartphone-dermatoscope is a safe, feasible tool that may improve the identification of connective tissue disease associated with ...

8. rmdopen.bmj.com rmdopen.bmj.com/content/11/2/e005469

Multicentre retrospective detection of nailfold ... Nailfold videocapillaroscopy (NVC) is a reliable and safe technique for studying microcirculation, actually mainly in connective tissue diseases (CTDs).

9. sciencedirect.com sciencedirect.com/science/article/pii/S156899722030001X

Standardisation of nailfold capillaroscopy for the ... Capillaroscopy is a non-invasive and safe tool which allows the evaluation of the morphology of the microcirculation. Since its recent incorporation in the ...