Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00110

2 Trial Registration Date

2006-03-27

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Nil

5 Primary Sponsor

Division of Cardiology, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Jeffrey Wing Hong FUNG

ii Address

iii Phone

852-2683-8525

iv Email

jwhfung@chuk.edu.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Jeffrey Wing Hong FUNG

ii Address

iii Phone

852-2683-8525

iv Email

jwhfung@chuk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Effect of Theophylline to Prevent Contrast Induced Nephropathy in Patients With Renal Insufficiency

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-02-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Coronary Heart Disease & Chronic Renal Insufficiency

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Theophylline infusion in addition to N-acetylcysteine and saline hydration

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

once

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

No drug in addition to N-acetylcysteine and saline hydration

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion: 1. Patient willing to sign informed consent form 2. Patient over 18 years of age 3. Patient undergoing coronary angiography or intervention 4. Patient with a serum creatinine 1.30 to 4.52 mg/dL (115 to 400 umol/l) Exclusion: 1. Patient with known allergy to or have already taken N-acetylcysteine (Fluimucil), theophylline or contrast agents 2. Patinet is in acute renal failure (2 Cr level differ by 15% within 1 month) 3. Patient in cardiogenic shock 4. Patient with significant cardiac arrhythmia 5. Pregnant women 6. Patients with child bearing age without appropriate contraception 7. Current dialysis patient 8. Concomitant use of dopamine and mannitol

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2006-03-30

21 Target Sample Size

200

22 Recruitment Status

Recruiting

23 Primary Outcome

Development of contrast nephropathy, defined as an increase in serum creatinine concentration of > and = 0.5 mg/dL, or a reduction in estimated glomerular filtration rate of > and = 25% of the baseline value, within 48 hours after the procedure

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2006-06-02