Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510092
• Other study ID #: Im-CAD-001
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 2021

Study information

• Verified date: April 2021
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University Heart and Vascular Center	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	University of Debrecen

Country where clinical trial is conducted

Hungary, 

Outcome

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