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

Major Adverse Cardiovascular Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02072538
• Other study ID #: UHHD-BM-002
• Status: Withdrawn
• Phase: N/A
• First received: February 24, 2014
• Last updated: May 9, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• GRACE Score
• Major Adverse Cardiovascular Events
• Troponin T

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular event		30 days	Yes
Secondary	Major adverse cardiovascular event		90 days	Yes