Acute Coronary SyndromeNCT05303441
The Predictive and Diagnostic Value of Cystatin C and High Sensitive Troponin
An observational study of Acute Coronary Syndrome and Chronic Kidney Diseases, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chronic Kidney Diseases
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2022to 1 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic kidney disease having chest pain and administered to emergency department for differential diagnosis of chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting)
Who may be able to join
- Age over 18,
- chronic kidney diease having chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting) -
Who cannot join
- STEMI,
- age less than 18,
- missing data,
- patients referred to or accepted from another medical facility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Research and Training Hospital
Ankara, 06110
bedriye müge sönmez, assoc. prof, +905055823208, mugesonmez06@yahoo.com
elif hamzaçebioğlu, resident
About this study
Official title: The Predictive and Diagnostic Value of Using Cystatin C and High Sensitive Troponin Level Together for Diagnosis of ACS in Patients With Chronic Kidney Disease Coming to Emergency Department With Chest Pain
Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome
Read the detailed description
Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome and the final diagnosis of AMI will be adjudicated by 2 independent cardiologists.Serial troponin measurements and eGFR values will be proportioned. These values the will be evaluated and compared for patients with acute coronary syndrome(culprit lesion on conventional coronary angiography) and non-ACS ones . With these data we aim to facilitate the diagnosis of acute coronary syndrome,increase the specificity and sensitivity of cardiac troponins for the diagnosis of acute coronary syndrome of patients with chronic kidney disease, increase the utility of high sensitive troponins for patients with chronic kidney disease. Again, with these data, it is aimed to reduce the number of false negative and false positive diagnosis of acute coronary syndrome .
- Conditions
- Acute Coronary Syndrome, Chronic Kidney Diseases
- Being tested
- percutaneous coronary intervention
- Medical subject headings
- Acute Coronary Syndrome, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
conventional coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| patients with acute coronary syndrome | patients with chronic kidney disease having chest pain with ecg, symptom or cardiac troponin levels compatible with ACS Receives: Procedure: percutaneous coronary intervention | |
| patients without acute coronary syndrome | patients with chronic kidney disease having chest pain with ecg, symptom or cardiac troponin levels NONcompatible with ACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
anticipated ACS
The role of cystatin C in diagnosis acute coronary syndrome when used with troponin in patients with chronic renal failure.
Measured: time passed until PCI (percutaneous coronary intervention) (pre-intervention) or admission to hospital
exclusion of acs
exclusion of ACS according to current guidelines
Measured: time passed during emergency department visit until discharge avarage of 3-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Mar 2022
- Primary completion7 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedriye Muge Sonmez, Ankara Diskapi Training and Research Hospital
- Investigators
- bedriye müge sönmez, assoc. prof., Study director, research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303441
- Sponsor's protocol ID
- AnkaraDiskapiTRH
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamzacebioglu E, Sonmez BM, Akcay G, Tulmac M, Kayisoglu S, Hatil SI, Gungor EB. Valency of cystatin C and creatinine on troponin values in chronic kidney disease patients with chest pain in emergency department. Am J Emerg Med. 2025 Mar;89:95-102. doi: 10.1016/j.ajem.2024.12.020. Epub 2024 Dec 13.
PubMed 39705855
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive and Diagnostic Value of Using Cystatin C and High Sensitive Troponin Level Together for Diagnosis of ACS in Patients With Chronic Kidney Disease Coming to Emergency Department With Chest Pain
- ClinicalTrials.gov ID
- NCT05303441
- Acronym / sponsor ID
- AnkaraDiskapiTRH
- Conditions
- Acute Coronary Syndrome, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 31 Mar 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.
Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome
Detailed description
Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome and the final diagnosis of AMI will be adjudicated by 2 independent cardiologists.Serial troponin measurements and eGFR values will be proportioned. These values the will be evaluated and compared for patients with acute coronary syndrome(culprit lesion on conventional coronary angiography) and non-ACS ones . With these data we aim to facilitate the diagnosis of acute coronary syndrome,increase the specificity and sensitivity of cardiac troponins for the diagnosis of acute coronary syndrome of patients with chronic kidney disease, increase the utility of high sensitive troponins for patients with chronic kidney disease. Again, with these data, it is aimed to reduce the number of false negative and false positive diagnosis of acute coronary syndrome .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with acute coronary syndrome | – | Procedure: percutaneous coronary interventionpatients with chronic kidney disease having chest pain with ecg, symptom or cardiac troponin levels compatible with ACS |
| patients without acute coronary syndrome | – | –patients with chronic kidney disease having chest pain with ecg, symptom or cardiac troponin levels NONcompatible with ACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic kidney disease having chest pain and administered to emergency department for differential diagnosis of chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting)
Key inclusion criteria (2 listed)
- Age over 18,
- chronic kidney diease having chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting) -
Key exclusion criteria (4 listed)
- STEMI,
- age less than 18,
- missing data,
- patients referred to or accepted from another medical facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary interventionconventional coronary angiography | Procedure or surgery | patients with acute coronary syndrome |
Primary outcome
anticipated ACS
Time frame: time passed until PCI (percutaneous coronary intervention) (pre-intervention) or admission to hospital
The role of cystatin C in diagnosis acute coronary syndrome when used with troponin in patients with chronic renal failure.
exclusion of acs
Time frame: time passed during emergency department visit until discharge avarage of 3-6 hours
exclusion of ACS according to current guidelines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39705855Hamzacebioglu E, Sonmez BM, Akcay G, Tulmac M, Kayisoglu S, Hatil SI, Gungor EB. Valency of cystatin C and creatinine on troponin values in chronic kidney disease patients with chest pain in emergency department. Am J Emerg Med. 2025 Mar;89:95-102. doi: 10.1016/j.ajem.2024.12.020. Epub 2024 Dec 13.
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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.
bedriye müge sönmez, assoc. prof. study director
research
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 Chronic Kidney Diseases, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 31 Mar 2022. 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 Turkey (Türkiye). 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 bedriye müge sönmez, assoc. prof. (+903125962470, mugesonmez06@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anticipated ACS (time frame: time passed until PCI (percutaneous coronary intervention) (pre-intervention) or admission to hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303441, which also lists 1 linked publication.
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 31 Mar 2022.