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

Withdrawn

• Conditions: Major Adverse Cardiovascular Events; Troponin T; GRACE Score

• Registration Number: NCT02072538
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-09
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event	30 days

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event	90 days

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany