Renal Acute MI Study

April 1, 2019 updated by: Ingrid Hopper, Monash University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in renal function and structure
Time Frame: Baseline, discharge, 1 month, 6 months and 12 months
Baseline, discharge, 1 month, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
renal response to myocardial infarction
Time Frame: baseline, discharge, 1 month, 6 months and 12 months
baseline, discharge, 1 month, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-03/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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