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Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy

Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contrast-Induced Nephropathy

Intervention: N-acetylcysteine (Drug); Theophylline (Drug); 0.9% sodium chloride (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Isfahan University of Medical Sciences

Official(s) and/or principal investigator(s):
Mortaza Arabmomeni, M.D., Study Director, Affiliation: Isfahan University of Medical Sciences

Overall contact:
Mortaza Arabmomeni, M.D., Phone: 09131268466, Email: drmortezaarabmomeni@gmail.com


The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0. 5 mg/dL or ≥ 25% of the baseline value.

Clinical Details

Official title: Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Plasma creatinine level


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- adult patients

- candidate of elective coronary angiography or angioplasty

- at least moderate risk for contrast induced nephropathy

Exclusion Criteria:

- unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal

failure, end-stage renal disease

- unstable serum creatinine

- unstable hemodynamic

- intravascular administration of contrast material in the past month

- using theophylline or N-acetylcysteine in the past month,

- known hypersensitivity to theophylline or N-acetylcysteine

Locations and Contacts

Mortaza Arabmomeni, M.D., Phone: 09131268466, Email: drmortezaarabmomeni@gmail.com

Chamran Hospital, Isfahan, Iran, Islamic Republic of; Recruiting
Mortaza Arabmomeni, M.D., Phone: 09131268466, Email: drmortezaarabmomeni@gmail.com
Mortaza Arabmomeni, M.D., Principal Investigator
Additional Information

Related publications:

Albabtain MA, Almasood A, Alshurafah H, Alamri H, Tamim H. Efficacy of ascorbic acid, N-acetylcysteine, or combination of both on top of saline hydration versus saline hydration alone on prevention of contrast-Induced nephropathy: a prospective randomized study. J Interv Cardiol. 2013 Feb;26(1):90-6. doi: 10.1111/j.1540-8183.2012.00767.x. Epub 2012 Sep 20.

Starting date: September 2013
Last updated: March 13, 2014

Page last updated: August 23, 2015

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