Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibratio… (NCT03564522) | Clinical Trial Compass
CompletedNot Applicable
Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibration and Assessment of Therapies in Pediatric Pulmonary Hypertension
United States35 participantsStarted 2017-04-01
Plain-language summary
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.
Who can participate
Age range
6 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.