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

NCT03071835 | Completed

• 1 other identifier: 20150899
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathies; Heart Diseases; Aging Frailty

Keywords

Stem Cells; Cardiovascular; Quality of Life; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Cardiac Function via Cardiac MRI

  at 3, 5, 7, 9, and 13 Years

• Change in Cardiac Function via Cardiac CT

  at 3, 5, 7, 9, and 13 Years

• Evaluate Functional Capacity via the NYHA Class

  at 3, 5, 7, 9, and 13 Years

• 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

  at 3, 5, 7, 9, and 13 Years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

ISCI / University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Links

• Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine

Biospecimen

Retention: SAMPLES WITH DNA

Genetic testing will consist of collecting tissue and/or blood stored for future use.

MeSH Terms

Conditions

Cardiomyopathies; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Joshua M Hare, Md

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 7, 2017
• Study Start: June 23, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)