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Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

Primary Purpose

Autoimmune Diseases, Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

Percutaneous coronary intervention with new generation fully resorbable scaffold

About this trial

This is an interventional other trial for Autoimmune Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Semmelweis University Heart and Vascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Coronary artery diseae with revascularization indicated

Coronary artery disease not requiring revascularization

Arm Description

Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.

Subjects with coronary artery disease that do not require revascularization.

Outcomes

Primary Outcome Measures

Major adverse cardiac and cerebral events

Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold

Secondary Outcome Measures

Full Information

NCT ID

NCT02510092

First Posted

July 23, 2015

Last Updated

April 22, 2021

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

University of Debrecen

1. Study Identification

Unique Protocol Identification Number

NCT02510092

Brief Title

Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

March 2021 (Actual)

Study Completion Date

March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

University of Debrecen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Diseases, Coronary Artery Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coronary artery diseae with revascularization indicated

Arm Type

Active Comparator

Arm Description

Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.

Arm Title

Coronary artery disease not requiring revascularization

Arm Type

No Intervention

Arm Description

Subjects with coronary artery disease that do not require revascularization.

Intervention Type

Device

Intervention Name(s)

Percutaneous coronary intervention with new generation fully resorbable scaffold

Primary Outcome Measure Information:

Title

Major adverse cardiac and cerebral events

Description

Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold

Time Frame

From index procedure to 5 years

Other Pre-specified Outcome Measures:

Title

Intravascular ultrasound findings in coronaries

Description

Minimum Lumen Area (MLA)

Time Frame

At index procedure

Title

Intravascular ultrasound findings in coronaries

Description

Percent Atheroma Volume (PAV)

Time Frame

At index procedure

Title

Intravascular ultrasound findings in coronaries

Description

Area Stenosis (AS)

Time Frame

At index procedure

Title

Intravascular ultrasound findings in coronaries

Description

Negative or positive remodelling index (RI)

Time Frame

At index procedure

Title

Intravascular ultrasound findings in coronaries

Description

Intimal thickness (IT)

Time Frame

At index procedure

Title

Intravascular ultrasound findings in coronaries

Description

Calcification Index (CI)

Time Frame

At index procedure

Title