Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result

NCT ID: NCT02072538

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score \>140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.

Detailed Description

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Conditions

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Major Adverse Cardiovascular Events Troponin T GRACE Score

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-discharge stress testing

Stress-testing (e.g. treadmill exercise test, stress-echochardiography)

No interventions assigned to this group

Post-discharge stress testing

Stress-testing (e.g. treadmill exercise test, stress-echochardiography)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients presenting to the emergency department ("chest pain unit")
* typical angina pectoris
* absence of symptoms since presentation
* at least 18 years
* low GRACE risk score (\<140 points)
* informed consent, signed agreement

Exclusion Criteria

* conditions with need for immediate workup
* mental disorders
* dementia
* pregnancy, breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Professor Hugo Katus

Head of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evangelos Giannitsis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Hugo A Katus, MD

Role: STUDY_CHAIR

University Hospital Heidelberg

Locations

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University Hospital Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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UHHD-BM-002

Identifier Type: -

Identifier Source: org_study_id

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