An observational study in Cardiomyopathies, Heart Diseases and Aging Frailty, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by University of Miami · Observational
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 47 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population for this study will consist of subjects who previously participated at an ISCI Trial and who are able to consent to being followed past their Follow-On visit.
Exclusion Criteria:
Continued Improvement in subject's symptoms
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
Change in Cardiac Function via Cardiac MRI
Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI
Time frame: at 3, 5, 7, 9, and 13 Years
Change in Cardiac Function via Cardiac CT
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 the NYHA Class
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
Evaluate Functional Capacity via the Six Minute Walk Test
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate change in Quality of Life via the Minnesota Living with Heart Failure
Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate change in Symptoms via cardiac events
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)
Time frame: at 3, 5, 7, 9, and 13 Years
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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