Renal Acute MI Study

Myocardial Infarction Clinical Trial

Official title:

Renal Structural, Functional and Cytokine Responses to Acute Myocardial Injury in Man

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580566
• Other study ID #: CP-03/11
• Status: Completed
• Start date: March 2012
• Est. completion date: September 2018

Study information

• Verified date: April 2019
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Kidney Function
• Myocardial Infarction

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in renal function and structure		Baseline, discharge, 1 month, 6 months and 12 months
Secondary	renal response to myocardial infarction		baseline, discharge, 1 month, 6 months and 12 months