Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Autoimmune Diseases
• Intervention / Treatment: Device: Percutaneous coronary intervention with new generation fully resorbable scaffold

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University Heart and Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coronary artery diseae with revascularization indicated; Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.	Device: Percutaneous coronary intervention with new generation fully resorbable scaffold
No Intervention: Coronary artery disease not requiring revascularization; Subjects with coronary artery disease that do not require revascularization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebral events	Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold	From index procedure to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravascular ultrasound findings in coronaries	Minimum Lumen Area (MLA)	At index procedure
Intravascular ultrasound findings in coronaries	Percent Atheroma Volume (PAV)	At index procedure
Intravascular ultrasound findings in coronaries	Area Stenosis (AS)	At index procedure
Intravascular ultrasound findings in coronaries	Negative or positive remodelling index (RI)	At index procedure
Intravascular ultrasound findings in coronaries	Intimal thickness (IT)	At index procedure
Intravascular ultrasound findings in coronaries	Calcification Index (CI)	At index procedure
Optical coherence tomography findings in coronaries	Intima to Media ratio (I/M ratio)	At index procedure
Optical coherence tomography findings in coronaries	Excentric intima hyperplasia	At index procedure
Optical coherence tomography findings in coronaries	Thin Cap Fibroatheroma presence (TCFA)	At index procedure
Optical coherence tomography findings in coronaries	Macrophage infiltration	At index procedure
Optical coherence tomography findings in coronaries	Intramural hematoma formation	At index procedure
Optical coherence tomography findings in coronaries	Intimal laceration	At index procedure
Optical coherence tomography findings in coronaries	Microchannel formation	At index procedure
Optical coherence tomography findings in coronaries	Lipid pool formation	At index procedure

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Collaborators: University of Debrecen

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Autoimmune Diseases
• Other Study ID Numbers: Im-CAD-001