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

Role of Pre-discharge vs. Early Post-discharge Stress Testing and Implementation of the GRACE Risk Score for Safe Discharge of Patients With an ACS and a Negative High Sensitivity Troponin T Result Within 3 Hours After Presentation to a Chest Pain Unit

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02072538

Enrollment

Registered

2014-02-26

Start date

2014-04-30

Completion date

2015-04-30

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GRACE Score, Major Adverse Cardiovascular Events, Troponin T

Keywords

Stress testing, Troponin T, GRACE score, Outcome

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Major adverse cardiovascular event	30 days

Secondary

Measure	Time frame
Major adverse cardiovascular event	90 days

Countries

Germany

Outcome results