Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction

April 15, 2024 updated by: National Taiwan University Hospital
The project is planed to explore the impact of LTBP4 and other matrix protein and potentially related biomarkers on renal outcomes, cardiac outcomes and all-cause mortality in patients with suspected acute coronary syndrome (ACS).

Study Overview

Status

Recruiting

Conditions

Detailed Description

The investigators will collect the blood samples from patients with suspect ACS. LTBP4 will be the first matrix protein that are going to understand. Upon hospital arrival, blood samples around 8 ml will be collected and the 2nd collection will be two weeks to one month after the event. The third collection will be one year later. In the between, if any ACS event develop, blood samples will be collected as protocols.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects between 20-80 yrs, with acute coronary syndrome in NTUH.

Description

Inclusion Criteria:

- acute coronary syndrome patients

Exclusion Criteria:

- cardiogenic shock, pregnancy, end-stage renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
suspect acute coronary syndrome

Subjects with the diagnosis of suspected acute coronary syndrome (ACS), age between 20 to 80.

Exclusion criteria: pregnant women, patients with end-stage renal disease (eGFR <15 mL/min/1.73 m2), cardiogenic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 3 years
3 years
Change of renal functions
Time Frame: One month, Six month and one year
The investigators will follow up Cr and eGFR levels correlate with LTBP4 levels
One month, Six month and one year
Incidence of hospitalization
Time Frame: 3 years
3 years
Incidence of required myocardial revascularization
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103008RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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