Renal Acute MI Study

NCT01580566 | Completed

• 1 other identifier: CP-03/11
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Kidney Function

Keywords

Myocardial Infarction (MI); Kidney function; bio-markers

Outcome Measures

Primary Outcomes (1)

• changes in renal function and structure

  Baseline, discharge, 1 month, 6 months and 12 months

Secondary Outcomes (1)

• renal response to myocardial infarction

  baseline, discharge, 1 month, 6 months and 12 months

Study Arms (4)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples to measure bio-markers

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Henry Krum, MBBS FRACP PhD

  Alfred Hospital/Monash.University

  PRINCIPAL INVESTIGATOR

• Henry Krum, MBBS FRACP PhD

  Alfred Hospital/Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seniour Lecturer

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 19, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: September 1, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

AU (1)