Renal Acute MI Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Monash University
Sponsor:
Information provided by (Responsible Party):
Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier:
NCT01580566
First received: April 12, 2012
Last updated: March 6, 2014
Last verified: March 2014

April 12, 2012
March 6, 2014
March 2012
December 2015   (final data collection date for primary outcome measure)
changes in renal function and structure [ Time Frame: Baseline, discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01580566 on ClinicalTrials.gov Archive Site
renal response to myocardial infarction [ Time Frame: baseline, discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Acute MI Study
Renal Structural, Functional and Cytokine Responses to Acute Myocardial Injury in Man

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.

Chronic heart and kidney disease are increasingly common in Western society. Both conditions are associated with frequent hospitalisation and increased mortality. Furthermore, there are mechanistic reasons why one condition may beget the other; the so-called "cardiorenal syndrome". The investigators therefore wish 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). The investigators also wish to determine if the renal response to a myocardial infarction is a predictor of the patients future health. To do this the investigators will measure markers of kidney function at the time of the heart attach, at discharge, 1 month, 6 months and 12 months and correlate this with the patients clinical condition.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples to measure bio-markers

Probability Sample

Patients who have presented to the Emergency Department with chest pain caused by a possible myocardial infarction.

  • Myocardial Infarction
  • Kidney Function
Not Provided
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
June 2016
December 2015   (final data collection date for primary outcome measure)

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

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
Both
18 Years and older
No
Contact: Henry Krum, MBBS FRACP PhD +613 9903 0042 henry.krum@monash.edu
Australia
 
NCT01580566
CP-03/11
No
Prof Henry Krum, Monash University
Monash University
Not Provided
Principal Investigator: Henry Krum, MBBS FRACP PhD Alfred Hospital/Monash.University
Principal Investigator: Henry Krum, MBBS FRACP PhD Alfred Hospital/Monash University
Monash University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP