Biopsy Collection and Repository Database | NCT05521503

Studies
Biopsy Collection and Repository Database

NCT05521503

Sponsor

Kenneth S. Campbell

Status

Recruiting

Last Update Posted

Feb 3, 2026Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2021Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Aug 20, 2022

First Submission Date that Met QC Criteria

Aug 25, 2022

First Posted Date

Aug 30, 2022Actual

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

Jan 30, 2026

Last Update Posted Date

Feb 3, 2026Actual

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

Use samples procured from patients to improve understanding of molecular, cellular, and tissue-level processes produced by a variety of cardiac diseases and therapeutic interventions.

Detailed Description

This is a prospective study enrolling patients referred for or undergoing cardiovascular procedures or treatment at the University of Kentucky. The study aims to facilitate the discovery of novel diagnostic biomarkers and therapeutic targets and improve the pathophysiological understanding of cardiac conditions.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological specimens		Biological specimens taken from cardiovascular procedures

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discover and quantify the concentration of novel diagnostic and prognostic biomarkers	Use biospecimens procured from patients with cardiac conditions to identify diagnostic surrogate biomarkers using discovery proteomics. In Cardiac Amyloidosis, the serum levels will be compared between confirmed ATTR and non-ATTR heart failure patients and a diagnostic threshold will be established. The research aims to advance understanding of cardiac diseases and to support the development of improved therapies.	12/21/2021-12/31/2030

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

Exclusion Criteria:

Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.

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

All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kenneth S Campbell, PhD	Contact	(859) 323-8157		k.s.campbell@uky.edu
Jennifer Isaacs, MS, MS	Contact	(859) 323-4738		jennifer.isaacs@uky.edu

Overall Officials

Name	Affiliation	Role
Kenneth S Campbell, PhD	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky	Recruiting	Lexington	Kentucky	40536	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Description

During this study, tissue samples (blood, urine and/or myocardial tissue) will be used to help identify trends in biomarkers and other information for patients with Cardiac Amyloidosis and other Cardiovascular conditions. No clinically important information that could be used by the subject will be identified. Therefore, the results of these studies will not be shared with the subjects.