Metabolic Syndrome and Contrast Induced Nephropathy

NCT02192372 | Completed

• 1 other identifier: MetS CIN
• Study Type: observational
• Target: 599
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contrast Induced Nephropathy; Metabolic Syndrome

Keywords

creatinine; glomerular filtration rate; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• glomerular filtration rate

  48 hours after the percutaneous coronary intervention

Other Outcomes (1)

• Cut-off point for baseline glomerular filtration rate to predict development of contrast induced nephropathy

  baseline glomerular filtration rate

Study Arms (2)

metabolic syndrome

Presence of 3 or more of these components: high fasting glucose (fasting serum glucose ≥ 100 mg/dl or drug treatment for elevated blood glucose), abdominal obesity (given as waist circumference \> 102 cm in men and \> 88 cm in women), high blood pressure (≥130/≥85 mmHg or drug treatment for hypertension), hypertriglyceridemia (serum triglycerides ≥150 mg/dl), low high-density lipoprotein cholesterol (\<40 mg/dl in men and \<50 mg/dl in women).

control

Age and sex adjusted control subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective percutaneous coronary intervention Patients with metabolic syndrome

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University School Of Medicine, Department of Cardiology

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• Ozcan OU, Adanir Er H, Gulec S, Ustun EE, Gerede DM, Goksuluk H, Tulunay Kaya C, Erol C. Impact of metabolic syndrome on development of contrast-induced nephropathy after elective percutaneous coronary intervention among nondiabetic patients. Clin Cardiol. 2015 Mar;38(3):150-6. doi: 10.1002/clc.22364.

  PMID: 25800136 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ozgur Ulas Ozcan

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

TU (1)