Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Autoimmune Diseases
• Interventions: Device: Percutaneous coronary intervention with new generation fully resorbable scaffold

• Registration Number: NCT02510092
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-24
• Study First Posted: 2015-07-28
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary artery diseae with revascularization indicated	Percutaneous coronary intervention with new generation fully resorbable scaffold	Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary