Optimised Procedure in Patients With NSTEMI and CKD

Chronic Kidney Disease Clinical Trial

— NSTEMI-CKD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02543177
• Other study ID #: 14-088
• Status: Terminated
• Phase: N/A
• First received: September 4, 2015
• Last updated: October 4, 2016
• Start date: September 2015
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: District Government Cologne, Department 24
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Infarction
• Kidney Diseases
• Myocardial Infarction
• Non-ST-segment Elevation Myocardial Infarction
• Renal Insufficiency, Chronic

Intervention

Procedure:
• coronary angiography

• ischemic precondition
four cycles of congestion and flow of blood in the arm of the patient for 5 minutes
• prior kidney irrigation

Locations

Country	Name	City	State
Germany	Prof. Dr. Michael Becker	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

Goldenberg I, Subirana I, Boyko V, Vila J, Elosua R, Permanyer-Miralda G, Ferreira-González 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. — View 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. — View 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. — View Citation

Szummer K, Lundman P, Jacobson SH, Schön S, Lindbäck 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of coronary adverse events between the four groups		1 month	No