Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibration and Assessment of Therapies in Pediatric Pulmonary Hypertension
Completed
Conditions studied: Pulmonary Hypertension, Congenital Heart Disease, Pediatric Congenital Heart Disease
In brief
This study looks to develop a multi-scale computational model of Pulmonary Hypertension, this clinical model will be calibrated using longitudinal, retrospectively and prospectively acquired human clinical data.
Key facts
- Study ID
- NCT03564522
- Run by
- University of Michigan
- People needed
- 35
- Starts
- 2017-04-01
- Expected to finish
- 2023-07-28
- Last updated by the study team
- 2024-04-18
Who can join
Age: 6 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients has been clinically diagnosed with pulmonary hypertension (>25 mmHg) or patient is a biopsy-proven non-rejecting cardiac transplant recipient
- Receiving partial or full care from pediatric cardiology team at Mott Children's Hospital (may have a primary cardiologist elsewhere).
You may not qualify if…
- Girls and women who are pregnant or actively trying to become pregnant
- Patients with significant neurocognitive impairment that precludes their ability to sign a consent form
- Patient has a contraindication to right-heart catheterization (RHC) examination, which includes patients with hypoxia and those who have difficulty maintaining supine position for the procedure.
- Patients with the following genetic syndromes:Trisomy 21 if unable to assent or consent, Trisomy 18,Trisomy 13, Other genetic syndromes at the discretion of the Primary Investigator
- Patients with unrepaired single ventricles (i.e., Pre-Fontan physiology)
- Patients who have heart failure and are deemed to be high risk to undergo tests that require sedation/anesthesia.
- Patients who require IV sedation or general anesthesia for research only MRI
- Patients with a pacemaker/internal defibrillator will be excluded from MRI PORTION ONLY
Where it is running
- Mott Children's Hospital University of Michigan — Ann Arbor, Michigan, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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