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
  Purpose

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.


Condition
Myocardial Infarction
Kidney Function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Renal Structural, Functional and Cytokine Responses to Acute Myocardial Injury in Man

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • changes in renal function and structure [ Time Frame: Baseline, discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal response to myocardial infarction [ Time Frame: baseline, discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples to measure bio-markers


Estimated Enrollment: 160
Study Start Date: March 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580566

Contacts
Contact: Henry Krum, MBBS FRACP PhD +613 9903 0042 henry.krum@monash.edu

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Henry Krum, MBBS FRACP PhD    +613 9903 0042    henry.krum@monash.edu   
Principal Investigator: Henry Krum, MBBS FRACP PhD         
Sponsors and Collaborators
Monash University
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Alfred Hospital/Monash.University
Principal Investigator: Henry Krum, MBBS FRACP PhD Alfred Hospital/Monash University
  More Information

No publications provided

Responsible Party: Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier: NCT01580566     History of Changes
Other Study ID Numbers: CP-03/11
Study First Received: April 12, 2012
Last Updated: March 6, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Monash University:
Myocardial Infarction (MI)
Kidney function
bio-markers

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014