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
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedApril 23, 2021
April 1, 2021
5.7 years
July 23, 2015
April 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Intravascular ultrasound findings in coronaries
At index procedure
Intravascular ultrasound findings in coronaries
At index procedure
Intravascular ultrasound findings in coronaries
At index procedure
- +11 more other outcomes
Study Arms (2)
Coronary artery diseae with revascularization indicated
ACTIVE COMPARATORSubjects with coronary artery disease, that require and are eligible for percutaneous revascularization.
Coronary artery disease not requiring revascularization
NO INTERVENTIONSubjects with coronary artery disease that do not require revascularization.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University Heart and Vascular Center
Budapest, 1122, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 28, 2015
Study Start
July 1, 2015
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
April 23, 2021
Record last verified: 2021-04