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

NCT02072538 | Withdrawn

• 1 other identifier: UHHD-BM-002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Adverse Cardiovascular Events; Troponin T; GRACE Score

Keywords

Stress testing; Troponin T; GRACE score; Outcome

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular event

  30 days

Secondary Outcomes (1)

• Major adverse cardiovascular event

  90 days

Study Arms (2)

Pre-discharge stress testing

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

Post-discharge stress testing

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to our emergency department ("chest pain unit") with typical angina pectoris are being screened for participation. Those meeting the inclusion criteria (typical angina pectoris, absence of symptoms since presentation, low GRACE risk score) are included.

You may qualify if:

• 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

You may not qualify if:

• conditions with need for immediate workup
• mental disorders
• dementia
• pregnancy, breast feeding

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Study Officials

• Evangelos Giannitsis, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Hugo A Katus, MD

  University Hospital Heidelberg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DE (1)