Optimised Procedure in Patients With NSTEMI and CKD

Study Overview
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Brief Summary
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Aim of the study is the determination of the ideal timepoint for the treatment of patients with acute Non-ST-segment Elevation Myocardial Infarction (NSTEMI) and an acute or chronic kidney disease (CKD) with a GRACE score < 140. It should be determine if a prompt coronary angiography or the protection of the kidneys from the used contrast agent is more important for the outcome of the patients. Additionally it will be investigated if the ischemic precondition can help to prevent heart damages.

Detailed Description
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According to international guidelines a coronary angiography has to be performed within 72h for patients with (NSTEMI). Patients with a GRACE score > 140 belong to the high risk group and the coronary angiography has to be performed within 24h. Until today for patients with a GRACE score > 140 and an acute or chronic kidney disease (CKD) the best approach is not known even though up to 40% of all NESTMI patients belong to this population. CKD in connection with an NSTEMI is one predictor for short and long term mortality and serious bleeding as a complication of coronary angiography. Additionally patient with CKD are at risk to experience a contrast agent induced aggravation of the CKD right up to a kidney failure. The pre- and post treatment of the kidneys seem to reduce this risk. The irrigation of the kidneys up to 48h prior coronary angiography optimises the kidney function and buffers the aggravation of kidney function caused by fluid loss or abstention at home. Additionally the influence of ischemic precondition on one arm of the patient will be evaluated in this setting. First studies give a hint that the kidneys may be protected against the contrast agent of the following catheter examination by ischemic precondition.

Official Title
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Optimised Procedure in Patients With an Acute Non-ST-segment Elevation Myocardial Infarction and Acute or Chronic Kidney Disease

Conditions
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Non-ST-segment Elevation Myocardial Infarction, Chronic Kidney Disease

Intervention / Treatment
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* Procedure: coronary angiography
* Procedure: ischemic precondition
* Procedure: prior kidney irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with an acute NSTEMI patient with a GRACE score < 140 patient with an acute or a chronic kidney disease (stage 1 - 5) patient who agree with the randomized assignment to one of the study groups in written signed Informed content prior to study inclusion patient who are legally competent at the time of study inclusion Exclusion Criteria: pregnancy nursing women patient has been committed to an institution by legal or regulatory order Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study participation in a parallel clinical trial subjects who are in any state of dependency to the investigators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>direct coronary angiography | Procedure: coronary angiography<br> <br> |
| Experimental: group B<br>direct coronary angiography plus ischemic precondition | Procedure: coronary angiography<br> <br> Procedure: ischemic precondition<br>* four cycles of congestion and flow of blood in the arm of the patient for 5 minutes<br>|
| Experimental: group C<br>delayed coronary angiography; the kidneys will be irrigated prior to coronary angiography | Procedure: coronary angiography<br> <br> Procedure: prior kidney irrigation<br> <br> |
| Experimental: group D<br>delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography | Procedure: coronary angiography<br> <br> Procedure: ischemic precondition<br>* four cycles of congestion and flow of blood in the arm of the patient for 5 minutes<br>Procedure: prior kidney irrigation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of coronary adverse events between the four groups |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI, CKD