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NCT04998227 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04998227
Other study ID # 202103008RINB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 26, 2021
Est. completion date March 1, 2025

Study information
Verified date April 2024
Source National Taiwan University Hospital
Contact Chi-Ting Su, MD. MPH, PhD
Phone +886972652878
Email A01218@ntucc.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - acute coronary syndrome patients Exclusion Criteria: - cardiogenic shock, pregnancy, end-stage renal disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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