Renal Acute MI Study

NCT ID: NCT01580566

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-09-30

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.

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.

Conditions

Myocardial Infarction; Kidney Function

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

No interventions assigned to this group

Group 3 - Acute STEMI without chronic kidney disease

Acute STEMI patients (n=40), without chronic kidney disease (defined as eGFR ≥60ml/min).

No interventions assigned to this group

Group 4 - Acute STEMI with kidney disease

Acute STEMI patients (n=40), with evidence of background chronic kidney disease (eGFR \<60ml/min).

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Hopper

Seniour Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Krum, MBBS FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Alfred Hospital/Monash.University

Henry Krum, MBBS FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Alfred Hospital/Monash University

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

CP-03/11

Identifier Type: -

Identifier Source: org_study_id