Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

April 22, 2021 updated by: Semmelweis University Heart and Vascular Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From index procedure to 5 years
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
Time Frame: At index procedure
Minimum Lumen Area (MLA)
At index procedure
Intravascular ultrasound findings in coronaries
Time Frame: At index procedure
Percent Atheroma Volume (PAV)
At index procedure
Intravascular ultrasound findings in coronaries
Time Frame: At index procedure
Area Stenosis (AS)
At index procedure
Intravascular ultrasound findings in coronaries
Time Frame: At index procedure
Negative or positive remodelling index (RI)
At index procedure
Intravascular ultrasound findings in coronaries
Time Frame: At index procedure
Intimal thickness (IT)
At index procedure
Intravascular ultrasound findings in coronaries
Time Frame: At index procedure
Calcification Index (CI)
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Intima to Media ratio (I/M ratio)
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Excentric intima hyperplasia
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Thin Cap Fibroatheroma presence (TCFA)
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Macrophage infiltration
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Intramural hematoma formation
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Intimal laceration
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Microchannel formation
At index procedure
Optical coherence tomography findings in coronaries
Time Frame: At index procedure
Lipid pool formation
At index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

University of Debrecen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Im-CAD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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