Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2018
Sample size
Target
Accrual to date
Final
50
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01580566