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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT02510092 |
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Date of registration:
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23/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment
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Scientific title:
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In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02510092 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Hungary
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Autoimmune Diseases
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Intervention(s)
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Device: Percutaneous coronary intervention with new generation fully resorbable scaffold
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Primary Outcome(s)
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Major adverse cardiac and cerebral events
[Time Frame: From index procedure to 5 years]
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Secondary ID(s)
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Im-CAD-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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