Autoimmune Diseases, Coronary Artery Disease
Conditions
Brief summary
This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.
Detailed description
The aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population. 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.
Interventions
DEVICEPercutaneous coronary intervention with new generation fully resorbable scaffold
Sponsors
University of Debrecen
Semmelweis University Heart and Vascular Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age of 18+ years * 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
* Age of 75+ years * Glomerular filtration rate of under 30 ml/min * Severely decreased left ventricular function (ejection fraction \<35%) * Pregnancy or nursing * Unclear immunological diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebral events | From index procedure to 5 years | Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intravascular ultrasound findings in coronaries | At index procedure | Minimum Lumen Area (MLA) |
| Optical coherence tomography findings in coronaries | At index procedure | Intima to Media ratio (I/M ratio) |
Countries
Hungary
Outcome results
None listed