A Comparative Study of Subjects Past Their Final Follow-O... | NCT03071835

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

NCT03071835

Sponsor

University of Miami

Status

Completed

Last Update Posted

Oct 18, 2023Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Cardiomyopathies
Heart Diseases
Aging Frailty

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2016Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Feb 13, 2017

First Submission Date that Met QC Criteria

Mar 1, 2017

First Posted Date

Mar 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2023

Last Update Posted Date

Oct 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joshua M Hare, Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute, University of MiamiPrincipal Investigator

Lead Sponsor

University of MiamiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

47Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joshua M Hare, Md	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ISCI / University of Miami Miller School of Medicine		Miami	Florida	33136	United States

References Module

Citations

Not provided

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases