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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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12 December 2020 |
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Main ID: |
NCT02235883 |
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Date of registration:
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26/08/2014 |
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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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High Performance Computing of Personalized Cardio Component Models
HEART |
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Scientific title:
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High Performance Computing of Personalized Cardio Component Models |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02235883 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Romania
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Contacts
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Name:
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Constantin Suciu, Conf. dr. ing. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Siemens Corporate Technology Romania |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age >18 years
- providing written informed consent
- scheduled to undergo clinically-indicated non-emergent invasive coronary angiography
(ICA)
- likelihood of stenosis in one of the main coronary epicardial vessels (LAD, LCx, RCA)
Exclusion Criteria:
- prior PCI
- prior bypass surgery
- prior valve surgery or replacement
- significant arrhythmia
- very low systolic BP (<90 mmHg)
- abnormally high HR (>120 bpm)
- significant Left Main disease
- STEMI or NSTEMI
- suspected microvascular disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Primary Outcome(s)
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Accuracy of coronary hemodynamic indices extracted from the computational model of the coronary circulation as compared to the invasively measured indices (FFR, basal Pd/Pa)
[Time Frame: up to 18 months]
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Secondary Outcome(s)
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Net reclassification index when using echocardiography data as input parameters for the computational model (in addition to the angiographic data)
[Time Frame: up to 18 months]
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Numerical correlation between computed and measured distal coronary pressure at rest and hyperemia
[Time Frame: up to 18 months]
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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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