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

October 4, 2016 updated by: RWTH Aachen University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Prof. Dr. Michael Becker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
direct coronary angiography
Procedure: coronary angiography
Experimental: group B
direct coronary angiography plus ischemic precondition
Procedure: coronary angiography
Procedure: ischemic precondition
four cycles of congestion and flow of blood in the arm of the patient for 5 minutes
Experimental: group C
delayed coronary angiography; the kidneys will be irrigated prior to coronary angiography
Procedure: coronary angiography
Procedure: prior kidney irrigation
Experimental: group D
delayed coronary angiography plus ischemic precondition; the kidneys will be irrigated prior to coronary angiography
Procedure: coronary angiography
Procedure: ischemic precondition
four cycles of congestion and flow of blood in the arm of the patient for 5 minutes
Procedure: prior kidney irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of coronary adverse events between the four groups
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Becker, Prof., Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine (Medical Clinic I)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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