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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01580566




Registration number
NCT01580566
Ethics application status
Date submitted
12/04/2012
Date registered
19/04/2012
Date last updated
3/04/2019

Titles & IDs
Public title
Renal Acute MI Study
Scientific title
Renal Structural, Functional and Cytokine Responses to Acute Myocardial Injury in Man
Secondary ID [1] 0 0
CP-03/11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Kidney Function 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Group 1 - Control - Non-Q wave MI subjects with normal cardiac and renal function (defined as eGFR >60ml/min) not undergoing a cardiac procedure involving contrast will serve as "control" for renal injury subjects.

Group 2 - stable CAD or non-Q wave MI - Patients undergoing coronary angiography +/- PCI for stable CAD or non-Q wave MI with normal cardiac and renal function (defined as eGFR >60ml/min) will control for the contrast STEMI patients are likely to receive as part of their post-MI management

Group 3 - Acute STEMI without chronic kidney disease - Acute STEMI patients (n=40), without chronic kidney disease (defined as eGFR =60ml/min).

Group 4 - Acute STEMI with kidney disease - Acute STEMI patients (n=40), with evidence of background chronic kidney disease (eGFR <60ml/min).

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
changes in renal function and structure
Timepoint [1] 0 0
Baseline, discharge, 1 month, 6 months and 12 months
Secondary outcome [1] 0 0
renal response to myocardial infarction
Timepoint [1] 0 0
baseline, discharge, 1 month, 6 months and 12 months

Eligibility
Key inclusion criteria
Age > 18 years

Have provided written informed consent

Group 1:

- Non-Q wave MI patients

- normal cardiac and renal function

- No use of contrast

- eGFR > 60ml/min

Group 2:

- Patients undergoing coronary angiography +/- PCI for stable CAD or non-Q wave MI

- normal cardiac and renal function

- eGFR > 60ml/min

Group 3:

- Acute STEMI Full thickness infarct (STEMI)

- eGFR = 60ml/min

Group 4:

- Acute STEMI Full thickness infarct (STEMI)

- eGFR < 60ml/min
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable or unwilling to comply with the study protocol

- Underlying medical condition which, in the opinion of the investigator, will effect
the safely or efficacy of the study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if a sizable myocardial infarction (heart attack)
results in negative changes to renal structure and function (i.e. has a negative impact on
the kidneys).

To determine if the renal response to a myocardial infarction is a predictor of the patients
future health.
Trial website
https://clinicaltrials.gov/show/NCT01580566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
Address 0 0
Alfred Hospital/Monash.University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications