Aging Frailty, Cardiomyopathies, Heart Diseases
Conditions
Keywords
Stem Cells, Cardiovascular, Quality of Life, Cardiomyopathy
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Miami
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be 18 years of age and older * Provide written informed consent * Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).
Exclusion criteria
* Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT. * Have a history of drug or alcohol abuse within the past 24 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continued Improvement in subject's symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Function via Cardiac CT | at 3, 5, 7, 9, and 13 Years | Evaluate Cardiac Function for changes, positive and negative via Cardiac CT |
| Evaluate Functional Capacity via the NYHA Class | at 3, 5, 7, 9, and 13 Years | Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination |
| Change in Cardiac Function via Cardiac MRI | at 3, 5, 7, 9, and 13 Years | Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI |
| Evaluate change in Quality of Life via the Minnesota Living with Heart Failure | at 3, 5, 7, 9, and 13 Years | Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire |
| Evaluate change in Symptoms via cardiac events | 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) |
| Evaluate Functional Capacity via the Six Minute Walk Test | at 3, 5, 7, 9, and 13 Years | Evaluate Functional Capacity via the Six Minute Walk Test |
Countries
United States
Outcome results
None listed