Optimised Procedure in Patients With NSTEMI and CKD

Not Applicable

Terminated

• Conditions: Non-ST-segment Elevation Myocardial Infarction; Chronic Kidney Disease
• Interventions: Procedure: coronary angiography; Procedure: prior kidney irrigation; Procedure: ischemic precondition

• Registration Number: NCT02543177
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	coronary angiography	direct coronary angiography plus ischemic precondition
group C	prior kidney irrigation	delayed coronary angiography; the kidneys will be irrigated prior to coronary angiography
group D	coronary angiography	delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography
group C	coronary angiography	delayed coronary angiography; the kidneys will be irrigated prior to coronary angiography
group D	ischemic precondition	delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography
group A	coronary angiography	direct coronary angiography
group B	ischemic precondition	direct coronary angiography plus ischemic precondition
group D	prior kidney irrigation	delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography

Primary Outcome Measures

Name	Time	Method
Comparison of coronary adverse events between the four groups	1 month

Trial Locations

Locations (1)

Prof. Dr. Michael Becker; 🇩🇪 Aachen, NRW, Germany