Myocardial InfarctionNCT01580566
Renal Acute MI Study
An observational study of Myocardial Infarction and Kidney Function, run by Monash University at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Kidney Function
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2012to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have presented to the Emergency Department with chest pain caused by a possible myocardial infarction.
Who may be able to join
- Age > 18 years
- Have provided written informed consent
- Group 1:
- Non-Q wave MI patients
- normal cardiac and renal function
- No use of contrast
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- Myocardial Infarction (MI), Kidney function, bio-markers
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
changes in renal function and structure
Measured: Baseline, discharge, 1 month, 6 months and 12 months
Secondary outcomes (1)
renal response to myocardial infarction
Measured: baseline, discharge, 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Hopper, Monash University
- Investigators
- Henry Krum, MBBS FRACP PhD, Principal investigator, Alfred Hospital/Monash.UniversityHenry Krum, MBBS FRACP PhD, Principal investigator, Alfred Hospital/Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580566
- Sponsor's protocol ID
- CP-03/11
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2012
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Structural, Functional and Cytokine Responses to Acute Myocardial Injury in Man
- ClinicalTrials.gov ID
- NCT01580566
- Acronym / sponsor ID
- CP-03/11
- Conditions
- Myocardial Infarction, Kidney Function
- Keywords
- Myocardial Infarction (MI), Kidney function, bio-markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have presented to the Emergency Department with chest pain caused by a possible myocardial infarction.
Key inclusion criteria (17 listed)
- Age > 18 years
- Have provided written informed consent
- Non-Q wave MI patients
- normal cardiac and renal function
- No use of contrast
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in renal function and structure
Time frame: Baseline, discharge, 1 month, 6 months and 12 months
1 secondary outcome
renal response to myocardial infarction
Time frame: baseline, discharge, 1 month, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
Related trials for Myocardial Infarction
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Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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Cardiogenic Shock Working Group Registry
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Breisgau PHENO-HEART MI
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Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Krum, MBBS FRACP PhD principal investigator
Alfred Hospital/Monash.University
Henry Krum, MBBS FRACP PhD principal investigator
Alfred Hospital/Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Kidney Function, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in renal function and structure (time frame: Baseline, discharge, 1 month, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.