Clinical trial NCT02510092: Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment
Official title: In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Diseases
Coronary Artery Disease
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: University of Debrecen
First posted: 2015-07-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebral events
timeFrame: From index procedure to 5 years
Secondary outcomes:
Other outcomes:
measure: Intravascular ultrasound findings in coronaries
timeFrame: At index procedure
measure: Intravascular ultrasound findings in coronaries
timeFrame: At index procedure
measure: Intravascular ultrasound findings in coronaries
timeFrame: At index procedure
measure: Intravascular ultrasound findings in coronaries
timeFrame: At index procedure
measure: Intravascular ultrasound findings in coronaries
timeFrame: At index procedure
measure: Intravascular ultrasound findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
measure: Optical coherence tomography findings in coronaries
timeFrame: At index procedure
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
Study officials:
References: