Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

Semmelweis University

Status: Completed

Conditions: Coronary Artery Disease; Autoimmune Diseases

Treatments: Device: Percutaneous coronary intervention with new generation fully resorbable scaffold

Study type: Interventional

Funder types: Other

Identifiers

NCT02510092

Im-CAD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Coronary artery diseae with revascularization indicated

Active Comparator group

Description:

Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.

Treatment:

Device: Percutaneous coronary intervention with new generation fully resorbable scaffold

Coronary artery disease not requiring revascularization

No Intervention group

Description:

Subjects with coronary artery disease that do not require revascularization.