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NCT Number: NCT02510092

Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

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.

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Key information

Conditions

Autoimmune Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Immune System Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention with new generation fully resorbable scaffold

Device

Primary outcomes

  1. 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

Other outcomes

  1. Intravascular ultrasound findings in coronaries

    Time frame: At index procedure

    Minimum Lumen Area (MLA)

  2. Intravascular ultrasound findings in coronaries

    Time frame: At index procedure

    Percent Atheroma Volume (PAV)

  3. Intravascular ultrasound findings in coronaries

    Time frame: At index procedure

    Area Stenosis (AS)

  4. Intravascular ultrasound findings in coronaries

    Time frame: At index procedure

    Negative or positive remodelling index (RI)

  5. Intravascular ultrasound findings in coronaries

    Time frame: At index procedure

    Intimal thickness (IT)

  6. Intravascular ultrasound findings in coronaries

    Time frame: At index procedure

    Calcification Index (CI)

  7. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Intima to Media ratio (I/M ratio)

  8. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Excentric intima hyperplasia

  9. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Thin Cap Fibroatheroma presence (TCFA)

  10. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Macrophage infiltration

  11. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Intramural hematoma formation

  12. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Intimal laceration

  13. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Microchannel formation

  14. Optical coherence tomography findings in coronaries

    Time frame: At index procedure

    Lipid pool formation

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Collaborators

  • University of Debrecen

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2015
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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