Ignite Creation Date:
2024-05-11 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399822
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-22
Brief Title:
Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease a Randomized Pilot Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Sjögrens 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 Raynauds 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
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 Raynauds 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
Detailed Description:
This is a pilot randomized controlled clinical trial This monocentric project will be carried out within the rheumatology department of the Quebec university hospital
The main objective of the project is to determine in patients with undifferentiated connective tissue disease to what extent capillaroscopy compared to usual care influences the proportion of patients obtaining a diagnosis of better characterized connective tissue disease in the first six months of follow-up
The secondary objectives are
1 Determine in patients with undifferentiated connective tissue disease to what extent capillaroscopy influences the following factors after capillaroscopy
The proportion of patients obtaining a diagnosis of better characterized connective tissue disease at 12 months
Medication changes addition discontinuation or change in dosage of non-biological disease modifying drugs biological disease modifying drugs medications for Raynauds syndrome and corticosteroids at 6 and 12 months
The number of medical visits in rheumatology medical visits in specialties other than rheumatology hospitalizations and emergency medical visits at 6 and 12 months
The number of additional examinations blood samples radiological examinations or others carried out which were prescribed by the treating rheumatologist at 6 and 12 months
A change in lifestyle habits smoking alcohol and drug consumption physical activity diet at 6 and 12 months
Patients quality of life assessed by the health assessment questionnaire short form survey-36 and Patient-Reported Outcomes Measurement Information System-29 questionnaires at 6 and 12 months
Patient acceptability and satisfaction with the intervention under study at 12 months
2 Evaluate the feasibility of recruiting participants in this study the investigators will measure the number proportions and rates of patients recruited and retained as well as the number of individuals screened eligible and recruited
The investigators will recruit 40 patients with a diagnosis of undifferentiated connective tissue disease and referred for a capillaroscopy examination in rheumatology as part of clinical practice
Once recruited participants will be randomized into two groups in a 11 ratio stratifying for gender and duration since the onset of the first symptoms of the disease less than three years and three years and more The randomization blocks will be generated by the biostatistician
In the intervention group a capillaroscopy will be performed in the month following recruitment In the control group capillaroscopy will be performed six months - two weeks after recruitment
The intervention studied as part of the project is capillaroscopy This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope This device magnifies the image of the capillaries to clearly visualize them Capillaries are the smallest blood vessels which allow the passage of only one red blood cell at a time At the nail bed they form a network of loops and are aligned next to each other This alignment allows them to be viewed over their entire length Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage
Participants will be invited to attend an appointment at the outpatient clinic to perform the capillaroscopy The date of this appointment will depend on the group into which they have been randomized If they are assigned to the intervention group capillaroscopy will be performed within one month after inclusion in the study If they are assigned to the control group capillaroscopy will be performed six months after inclusion in the study - two weeks If the capillaroscopy appointment is missed a new appointment will be scheduled within two weeks
The results of capillaroscopy will be reported qualitatively for all eight long fingers examined This approach was chosen since it best represents current clinical practice The capillaroscopy results will therefore be classified into one of the following categories normal nonspecific changes scleroderma pattern non-diagnostic quality
The main objective of the project is to determine in patients with undifferentiated connective tissue disease to what extent capillaroscopy compared to usual care influences the proportion of patients obtaining a diagnosis of better characterized connective tissue disease in the first six months of follow-up
The secondary objectives are
1 Determine in patients with undifferentiated connective tissue disease to what extent capillaroscopy influences the following factors after capillaroscopy
The proportion of patients obtaining a diagnosis of better characterized connective tissue disease at 12 months
Medication changes addition discontinuation or change in dosage of non-biological disease modifying drugs biological disease modifying drugs medications for Raynauds syndrome and corticosteroids at 6 and 12 months
The number of medical visits in rheumatology medical visits in specialties other than rheumatology hospitalizations and emergency medical visits at 6 and 12 months
The number of additional examinations blood samples radiological examinations or others carried out which were prescribed by the treating rheumatologist at 6 and 12 months
A change in lifestyle habits smoking alcohol and drug consumption physical activity diet at 6 and 12 months
Patients quality of life assessed by the health assessment questionnaire short form survey-36 and Patient-Reported Outcomes Measurement Information System-29 questionnaires at 6 and 12 months
Patient acceptability and satisfaction with the intervention under study at 12 months
2 Evaluate the feasibility of recruiting participants in this study the investigators will measure the number proportions and rates of patients recruited and retained as well as the number of individuals screened eligible and recruited
The investigators will recruit 40 patients with a diagnosis of undifferentiated connective tissue disease and referred for a capillaroscopy examination in rheumatology as part of clinical practice
Once recruited participants will be randomized into two groups in a 11 ratio stratifying for gender and duration since the onset of the first symptoms of the disease less than three years and three years and more The randomization blocks will be generated by the biostatistician
In the intervention group a capillaroscopy will be performed in the month following recruitment In the control group capillaroscopy will be performed six months - two weeks after recruitment
The intervention studied as part of the project is capillaroscopy This examination consists of visualizing the capillaries located at the base of the nail using a device called a capillaroscope This device magnifies the image of the capillaries to clearly visualize them Capillaries are the smallest blood vessels which allow the passage of only one red blood cell at a time At the nail bed they form a network of loops and are aligned next to each other This alignment allows them to be viewed over their entire length Researchers have described abnormalities in capillaries that are associated with certain diseases involving microvascular damage
Participants will be invited to attend an appointment at the outpatient clinic to perform the capillaroscopy The date of this appointment will depend on the group into which they have been randomized If they are assigned to the intervention group capillaroscopy will be performed within one month after inclusion in the study If they are assigned to the control group capillaroscopy will be performed six months after inclusion in the study - two weeks If the capillaroscopy appointment is missed a new appointment will be scheduled within two weeks
The results of capillaroscopy will be reported qualitatively for all eight long fingers examined This approach was chosen since it best represents current clinical practice The capillaroscopy results will therefore be classified into one of the following categories normal nonspecific changes scleroderma pattern non-diagnostic quality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None