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Optimised Procedure in Patients With NSTEMI and CKD (NSTEMI-CKD)

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
coronary angiography
ischemic precondition
prior kidney irrigation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST-segment Elevation Myocardial Infarction focused on measuring NSTEMI, CKD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. Dr. Michael Becker

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

group A

group B

group C

group D

Arm Description

direct coronary angiography

direct coronary angiography plus ischemic precondition

delayed coronary angiography; the kidneys will be irrigated prior to coronary angiography

delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography

Outcomes

Primary Outcome Measures

Comparison of coronary adverse events between the four groups

Secondary Outcome Measures

Full Information

First Posted
September 4, 2015
Last Updated
October 4, 2016
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02543177
Brief Title
Optimised Procedure in Patients With NSTEMI and CKD
Acronym
NSTEMI-CKD
Official Title
Optimised Procedure in Patients With an Acute Non-ST-segment Elevation Myocardial Infarction and Acute or Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
not enough patients recruited
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST-segment Elevation Myocardial Infarction, Chronic Kidney Disease
Keywords
NSTEMI, CKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
direct coronary angiography
Arm Title
group B
Arm Type
Experimental
Arm Description
direct coronary angiography plus ischemic precondition
Arm Title
group C
Arm Type
Experimental
Arm Description
delayed coronary angiography; the kidneys will be irrigated prior to coronary angiography
Arm Title
group D
Arm Type
Experimental
Arm Description
delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography
Intervention Type
Procedure
Intervention Name(s)
coronary angiography
Intervention Type
Procedure
Intervention Name(s)
ischemic precondition
Intervention Description
four cycles of congestion and flow of blood in the arm of the patient for 5 minutes
Intervention Type
Procedure
Intervention Name(s)
prior kidney irrigation
Primary Outcome Measure Information:
Title
Comparison of coronary adverse events between the four groups
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Becker, Prof.
Organizational Affiliation
Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine (Medical Clinic I)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. Michael Becker
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20498417
Citation
Goldenberg I, Subirana I, Boyko V, Vila J, Elosua R, Permanyer-Miralda G, Ferreira-Gonzalez I, Benderly M, Guetta V, Behar S, Marrugat J. Relation between renal function and outcomes in patients with non-ST-segment elevation acute coronary syndrome: real-world data from the European Public Health Outcome Research and Indicators Collection Project. Arch Intern Med. 2010 May 24;170(10):888-95. doi: 10.1001/archinternmed.2010.95.
Results Reference
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PubMed Identifier
12127921
Citation
Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. doi: 10.1053/euhj.2002.3193.
Results Reference
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PubMed Identifier
24856027
Citation
Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.
Results Reference
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PubMed Identifier
21873419
Citation
Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
Results Reference
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PubMed Identifier
20210836
Citation
Szummer K, Lundman P, Jacobson SH, Schon S, Lindback J, Stenestrand U, Wallentin L, Jernberg T; SWEDEHEART. Relation between renal function, presentation, use of therapies and in-hospital complications in acute coronary syndrome: data from the SWEDEHEART register. J Intern Med. 2010 Jul;268(1):40-9. doi: 10.1111/j.1365-2796.2009.02204.x. Epub 2009 Dec 3.
Results Reference
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PubMed Identifier
22735306
Citation
Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.
Results Reference
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PubMed Identifier
22445708
Citation
Bae EH, Lim SY, Cho KH, Choi JS, Kim CS, Park JW, Ma SK, Jeong MH, Kim SW. GFR and cardiovascular outcomes after acute myocardial infarction: results from the Korea Acute Myocardial Infarction Registry. Am J Kidney Dis. 2012 Jun;59(6):795-802. doi: 10.1053/j.ajkd.2012.01.016. Epub 2012 Mar 23.
Results Reference
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Optimised Procedure in Patients With NSTEMI and CKD

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