Acute Coronary SyndromeNCT04998227
Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction
An observational study of Acute Coronary Syndrome and Acute Coronary Syndrome With Renal Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Acute Coronary Syndrome With Renal Dysfunction
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Apr 2021to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects between 20-80 yrs, with acute coronary syndrome in NTUH.
Who may be able to join
- acute coronary syndrome patients
Who cannot join
- cardiogenic shock, pregnancy, end-stage renal disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chi-Ting Su, MD, MPH, PhD, A01218@ntucc.gov.tw
About this study
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).
Read the 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.
- Medical subject headings
- Acute Coronary Syndrome
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change of renal functions
The investigators will follow up Cr and eGFR levels correlate with LTBP4 levels
Measured: One month, Six month and one year
All cause mortality
Measured: 3 years
Incidence of hospitalization
Measured: 3 years
Incidence of required myocardial revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start26 Apr 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998227
- Sponsor's protocol ID
- 202103008RINB
- Status last verified
- Apr 2024
- First submitted
- 3 Aug 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction
- ClinicalTrials.gov ID
- NCT04998227
- Acronym / sponsor ID
- 202103008RINB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Aug 2021 (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.
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).
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects between 20-80 yrs, with acute coronary syndrome in NTUH.
Key inclusion criteria (1 listed)
- acute coronary syndrome patients
Key exclusion criteria (1 listed)
- cardiogenic shock, pregnancy, end-stage renal disease
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
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
All cause mortality
Time frame: 3 years
Incidence of hospitalization
Time frame: 3 years
Incidence of required myocardial revascularization
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Acute Coronary Syndrome and Acute Coronary Syndrome With Renal Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Ting Su, MD. MPH, PhD (+886972652878, A01218@ntucc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of renal functions (time frame: One month, Six month and one year). The study lists 4 primary outcomes in all. 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 17 Apr 2024.