A Comparative Study of Subjects Past Their Final Follow-ON Visit

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)

Conditions
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Cardiomyopathies, Heart Diseases, Aging Frailty

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3, 5, 7, 9, and 13 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiac Function via Cardiac MRI | Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI | 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 | 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 | 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 | 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 | 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) | at 3, 5, 7, 9, and 13 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cells, Cardiovascular, Quality of Life, Cardiomyopathy