Clinical trial NCT03071835: A Comparative Study of Subjects Past Their Final Follow-ON Visit
Official title: A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathies
Heart Diseases
Aging Frailty
Keywords: Stem Cells
Cardiovascular
Quality of Life
Cardiomyopathy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continued Improvement in subject's symptoms
timeFrame: at 3, 5, 7, 9, and 13 Years
Secondary outcomes:
measure: Change in Cardiac Function via Cardiac MRI
timeFrame: at 3, 5, 7, 9, and 13 Years
measure: Change in Cardiac Function via Cardiac CT
timeFrame: at 3, 5, 7, 9, and 13 Years
measure: Evaluate Functional Capacity via the NYHA Class
timeFrame: at 3, 5, 7, 9, and 13 Years
measure: Evaluate Functional Capacity via the Six Minute Walk Test
timeFrame: at 3, 5, 7, 9, and 13 Years
measure: Evaluate change in Quality of Life via the Minnesota Living with Heart Failure
timeFrame: at 3, 5, 7, 9, and 13 Years
measure: Evaluate change in Symptoms via cardiac events
timeFrame: at 3, 5, 7, 9, and 13 Years
Other outcomes:
Locations:
city: Miami
country: United States
facility: ISCI / University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Joshua M Hare, Md
role: PRINCIPAL_INVESTIGATOR
References: