Metabolic Syndrome and Contrast Induced Nephropathy

Sponsor

Ankara University (Other)

Overall Status

Completed

CT.gov ID

NCT02192372

Collaborator

(none)

599

Enrollment

Location

4.9

Duration (Months)

121.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy Metabolic Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

599 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Metabolic Syndrome on Development of Contrast Induced Nephropathy After Elective Percutaneous Coronary Intervention

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Contrast induced nephropathy [24-48 hours after the percutaneous coronary intervention]
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.

Secondary Outcome Measures

glomerular filtration rate [48 hours after the percutaneous coronary intervention]
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)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.