HYPERION: A Comparative Study of Subjects Past Their Final Follow-ON Visit
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be 18 years of age and older
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Provide written informed consent
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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:
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Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.
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Have a history of drug or alcohol abuse within the past 24 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | ISCI / University of Miami Miller School of Medicine | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Joshua M Hare, Md, University of Miami
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20150899