Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment
NCT ID: NCT02510092
Last Updated: 2021-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2015-07-31
2021-03-31
Brief Summary
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Detailed Description
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The following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. Furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. This may be linked to a long term exaggerated chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Coronary artery diseae with revascularization indicated
Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.
Percutaneous coronary intervention with new generation fully resorbable scaffold
Coronary artery disease not requiring revascularization
Subjects with coronary artery disease that do not require revascularization.
No interventions assigned to this group
Interventions
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Percutaneous coronary intervention with new generation fully resorbable scaffold
Eligibility Criteria
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Inclusion Criteria
* Signed and dated informed consent form
* Manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist
* Clinical indication for a coronary angiography as determined by a cardiologist
Exclusion Criteria
* Glomerular filtration rate of under 30 ml/min
* Severely decreased left ventricular function (ejection fraction \<35%)
* Pregnancy or nursing
* Unclear immunological diagnosis
18 Years
75 Years
ALL
No
Sponsors
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University of Debrecen
OTHER
Semmelweis University Heart and Vascular Center
OTHER
Responsible Party
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Locations
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Semmelweis University Heart and Vascular Center
Budapest, , Hungary
Countries
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Other Identifiers
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Im-CAD-001
Identifier Type: -
Identifier Source: org_study_id
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