Cardiovascular DiseasesBICARDNCT05521503
Biopsy Collection and Repository Database
An observational study of Cardiovascular Diseases, run by Kenneth S. Campbell at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2021to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Kenneth S Campbell, PhD, (859) 323-8157, k.s.campbell@uky.edu
Jennifer Isaacs, MS, MS, (859) 323-4738, jennifer.isaacs@uky.edu
About this study
Official title: Cardiac Biopsy Collection Repository and Database
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biological specimens | Biological specimens taken from cardiovascular procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12/21/2021-12/31/2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start21 Dec 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenneth S. Campbell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth S. Campbell, University of Kentucky
- Investigators
- Kenneth S Campbell, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521503
- Sponsor's protocol ID
- 73647
- Acronym
- BICARD
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Biopsy Collection Repository and Database
- ClinicalTrials.gov ID
- NCT05521503
- Acronym / sponsor ID
- BICARD / 73647
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kenneth S. CampbellUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological specimens | – | –Biological specimens taken from cardiovascular procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discover and quantify the concentration of novel diagnostic and prognostic biomarkers
Time frame: 12/21/2021-12/31/2030
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth S Campbell, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Kenneth S. Campbell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth S Campbell, PhD ((859) 323-8157, k.s.campbell@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discover and quantify the concentration of novel diagnostic and prognostic biomarkers (time frame: 12/21/2021-12/31/2030). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.