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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02192372
Other study ID # MetS CIN
Secondary ID
Status Completed
Phase N/A
First received July 15, 2014
Last updated July 15, 2014
Start date February 2014
Est. completion date July 2014

Study information

Verified date July 2014
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. An observational prospective cohort study was designed to determine whether metabolic syndrome predicts the development of contrast induced nephropathy after elective percutaneous coronary intervention.


Recruitment information / eligibility

Status Completed
Enrollment 599
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

Patients must be scheduled for elective percutaneous coronary intervention Clinical diagnosis of metabolic syndrome Patients must give informed consent

Exclusion Criteria:

Acute coronary events Acute renal failure End stage renal failure requiring hemodialysis Contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous coronary intervention Exposure to contrast agent within 1 week before the procedure.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Turkey Ankara University School Of Medicine, Department of Cardiology Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Cut-off point for baseline glomerular filtration rate to predict development of contrast induced nephropathy baseline glomerular filtration rate No
Primary Contrast induced nephropathy Contrast induced nephropathy was defined as an increase in serum creatinine of >25% or >0.5 mg/dl above the baseline value 24 or 48 hours after angiography. 24-48 hours after the percutaneous coronary intervention No
Secondary glomerular filtration rate Glomerular filtration rate was estimated using the Cockcroft-Gault formula: (140-age) x weight (kg)/ serum creatinine (mg/dl) x 72 (x 0.85 for females) 48 hours after the percutaneous coronary intervention No
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