NCT02543177

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

September 4, 2015

Last Update Submit

October 4, 2016

Conditions

Non-ST-segment Elevation Myocardial InfarctionChronic Kidney Disease

Keywords

NSTEMI, CKD

Outcome Measures

Primary Outcomes (1)

  • Comparison of coronary adverse events between the four groups

    1 month

Study Arms (4)

group A

EXPERIMENTAL

direct coronary angiography

Procedure: coronary angiography

group B

EXPERIMENTAL

direct coronary angiography plus ischemic precondition

Procedure: coronary angiographyProcedure: ischemic precondition

group C

EXPERIMENTAL

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

Procedure: coronary angiographyProcedure: prior kidney irrigation

group D

EXPERIMENTAL

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

Procedure: coronary angiographyProcedure: ischemic preconditionProcedure: prior kidney irrigation

Interventions

coronary angiographyPROCEDURE
group Agroup Bgroup Cgroup D
ischemic preconditionPROCEDURE

four cycles of congestion and flow of blood in the arm of the patient for 5 minutes

group Bgroup D
prior kidney irrigationPROCEDURE
group Cgroup D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Michael Becker

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (7)

  • 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.

    PMID: 20498417BACKGROUND

  • 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.

    PMID: 12127921BACKGROUND

  • 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.

    PMID: 24856027BACKGROUND

  • 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.

    PMID: 21873419BACKGROUND

  • 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.

    PMID: 20210836BACKGROUND

  • 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.

    PMID: 22735306BACKGROUND

  • 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.

    PMID: 22445708BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Michael Becker, Prof.

    Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine (Medical Clinic I)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

DE(1)