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

Completed

• Conditions: Heart Diseases; Cardiomyopathies; Aging Frailty

• Registration Number: NCT03071835
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study Start: 2016-06-23
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
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 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 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)

Trial Locations

Locations (1)

ISCI / University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States