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

Trial Summary

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 data supports the effectiveness of the treatment Nail Capillaroscopy for Connective Tissue Disease?

Nailfold capillaroscopy (NFC) is useful in diagnosing and assessing connective tissue diseases like systemic sclerosis and systemic lupus erythematosus. Changes in NFC findings over time can reflect changes in the clinical status of patients, making it an important tool for monitoring disease progression and treatment effectiveness. ^{1 2 3 4 5}

Is nailfold capillaroscopy safe for humans?

Nailfold capillaroscopy is a noninvasive method, meaning it doesn't involve entering the body or breaking the skin, and is generally considered safe for humans. ^{1 3 6 7 8}

How does capillaroscopy differ from other treatments for connective tissue disease?

Capillaroscopy is unique because it is a diagnostic imaging technique used to assess the blood capillary network in the nailfold area, rather than a drug or medication. It helps in diagnosing and monitoring conditions like systemic sclerosis by providing visual insights into microcirculation problems, which is different from traditional treatments that typically involve medication. ^{1 3 4 9 10}

What is the purpose of this trial?

Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD). Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established. Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly. Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc. However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.

Research Team

Laetitia Michou, MD PhD

Principal Investigator

CHU de Quebec (Université Laval)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[The diagnostic significance of nailfold video-capillaroscopy in systemic sclerosis]. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Nailfold capillaroscopy as a prognostic marker for connective tissue diseases: An observational clinico-epidemiological study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Qualitative and quantitative assessment of nailfold capillaries by capillaroscopy in healthy volunteers. [2012]

4. Germany pubmed.ncbi.nlm.nih.gov

The current role of capillaroscopy in vasculitides. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of nailfold videocapillaroscopic abnormalities in patients with systemic lupus erythematosus. [2019]

6. Switzerland 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. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Nailfold Capillaroscopy of Healthy Individuals - An Observational Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Comparison of Nailfold Capillaroscopy between Juvenile Systemic Lupus Erythematosus and Healthy Controls: Correlation with Laboratory and Clinical Parameters. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Clinical impact of nailfold capillaroscopy in daily clinical practice. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Image enhancement effect on inter and intra-observer reliability of nailfold capillary assessment. [2019]