Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00061

2 Trial Registration Date

2005-09-09

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

NONE

5 Primary Sponsor

NONE

6 Secondary Sponsor

NONE

Function

Please specify

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

i Name

Chan Yat Sun Joseph

ii Address

Prince of Wales Hospital, The Chinese University of Hong Kong

iii Phone

iv Email

jyschan@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Chan Yat Sun Joseph

ii Address

Prince of Wales Hospital, The Chinese University of Hong Kong

iii Phone

iv Email

jyschan@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Myocardial Protection with Glucose-Insulin-Potassium (GIK) in Patients Undergoing Percutaneous Coronary Interventions

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?

2003-01-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Glucose-Insulin-Potassium during Percutaneous Coronary Intervention (PCI)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Few hours

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

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: Patients undergoing elective PCI with normal, static or decreasing level of troponin levl

ii Exclusion Criteria

Exclusion Patients undergoing direct PCI for ST elevation myocardial infarction Patients on regular insuli therapy Patients with uncorrected hypokalaemia, hyperkalaemia, hypoglycemia or hyperglycemia Patients with rising level of troponin Patients with creatine level > 250

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

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2003-03-03

21 Target Sample Size

500

22 Recruitment Status

Unknown

23 Primary Outcome

Troponin rise after PCI

24 Secondary Outcome

Composite endpoint of 30 days major cardiovascular events post PCI

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

ChiCTR-TRC-05000653

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail