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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05303441
Other study ID # AnkaraDiskapiTRH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2022
Est. completion date February 1, 2023

Study information

Verified date March 2022
Source Ankara Diskapi Training and Research Hospital
Contact bedriye müge sönmez, assoc. prof.
Phone +903125962470
Email mugesonmez06@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 172
Est. completion date February 1, 2023
Est. primary completion date January 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age over 18, 2. chronic kidney diease having chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting) - Exclusion Criteria: 1. STEMI, 2. age less than 18, 3. missing data, 4. patients referred to or accepted from another medical facility

Study Design


Intervention

Procedure:
percutaneous coronary intervention
conventional coronary angiography

Locations

Country Name City State
Turkey Diskapi Research and Training Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary anticipated ACS The role of cystatin C in diagnosis acute coronary syndrome when used with troponin in patients with chronic renal failure. time passed until PCI (percutaneous coronary intervention) (pre-intervention) or admission to hospital
Primary exclusion of acs exclusion of ACS according to current guidelines time passed during emergency department visit until discharge avarage of 3-6 hours
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