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Non-ST-segment Elevation Myocardial InfarctionNSTEMI-CKDNCT02543177

Optimised Procedure in Patients With NSTEMI and CKD

A study testing coronary angiography, ischemic precondition and prior kidney irrigation in people with Non-ST-segment Elevation Myocardial Infarction and Chronic Kidney Disease, run by RWTH Aachen University at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
coronary angiography, ischemic precondition and prior kidney irrigation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteGermany
Study dates
Sep 2015to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Prof. Dr. Michael Becker

    Aachen, North Rhine-Westphalia, 52074

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
coronary angiography, ischemic precondition, prior kidney irrigation
Keywords
NSTEMI, CKD
Medical subject headings
Renal Insufficiency, Chronic, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coronary angiographyProcedure or surgery

  • ischemic preconditionProcedure or surgery

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

  • prior kidney irrigationProcedure or surgery

Study groups in NCT02543177
Study groupRoleWhat they receive
group AExperimentaldirect coronary angiography
Receives: Procedure: coronary angiography
group BExperimentaldirect coronary angiography plus ischemic precondition
Receives: Procedure: coronary angiography; Procedure: ischemic precondition
group CExperimentaldelayed coronary angiography; the kidneys will be irrigated prior to coronary angiography
Receives: Procedure: coronary angiography; Procedure: prior kidney irrigation
group DExperimentaldelayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography
Receives: Procedure: coronary angiography; Procedure: ischemic precondition; Procedure: prior kidney irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of coronary adverse events between the four groups

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2018 (estimated)

Why it stopped: not enough patients recruited

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543177
Sponsor's protocol ID
14-088
Acronym
NSTEMI-CKD
Status last verified
Oct 2016
First submitted
4 Sep 2015
Last updated
5 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20498417

  • 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.

    PubMed 12127921

  • 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.

    PubMed 24856027

  • 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.

    PubMed 21873419

  • 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.

    PubMed 20210836

  • 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.

    PubMed 22735306

  • 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.

    PubMed 22445708

Questions about this trial

What is this clinical trial studying?

A study testing coronary angiography, ischemic precondition and prior kidney irrigation in people with Non-ST-segment Elevation Myocardial Infarction and Chronic Kidney Disease, run by RWTH Aachen University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: not enough patients recruited). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of coronary adverse events between the four groups (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543177, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.

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