ISCI / University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
NCT Number: NCT03071835
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Miami, Florida, 33136, United States
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 3, 5, 7, 9, and 13 Years
Demonstrate change of subject's symptoms by assessing cardiac events over an extended period of time following participation in an ISCI cardiac trial where the subject received Investigational product.
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Cardiac Function for changes, positive and negative via Cardiac CT
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Functional Capacity via the Six Minute Walk Test
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Progression or Regression of disease (i.e. death, Left Ventricular Assist Device (LVAD), heart transplant and/or continuous intravenous infusion therapy (dobutamine, Milrinone, etc)
University of Miami
Other
A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
Acronym: HYPERION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03860935
Alzheimer Disease, Amyloid Cardiomyopathy
Los Angeles, California, United States
View Trial DetailsNCT04634708
Cardiomyopathies, Cardiovascular Diseases
Berlin, Germany
View Trial DetailsNCT02924285
Arrhythmias, Cardiac, Cardiac Complexes, Premature
Leipzig, Germany
View Trial DetailsNCT01905670
Cardiomyopathies, Cardiovascular Diseases
Prague, Czechia
View Trial Details