Safety and Efficacy of Hs-cTnT Protocols

Chest Pain Clinical Trial

Official title:

Safety and Efficacy of Hs-cTnT Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484544
• Other study ID #: HscTnTProtocols
• Status: Completed
• Start date: February 1, 2013
• Est. completion date: April 30, 2014

Study information

• Verified date: September 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chest pain is a common presenting complaint among patients in the emergency department (ED). A large portion of patients with chest pain undergo lengthy assessment in the ED or are admitted to rule out acute oronary syndrome (ACS), often with stress testing, creating a substantial health care burden. The new high-sensitivity cardiac troponin assays allow use of shorter time intervals for repeated blood samples and may improve care for chest pain patients. The aim of this cohort is to evaluate high-sentivity troponin based protocols for ruling out and ruling in ACS in the ED.

Description:

This is a prospective observational study conducted at Skåne University Hospital (Lund, Sweden). Patients presenting with non-traumatic chest pain and for whom hs-cTnT testing was ordered at presentation will be enrolled between february 2013 to April 2014 after providing written informed consent. Patients with STEMI during index visit and those with severe communication barriers will not be enrolled. Enrolled patients will have a second blood sample for hs-cTnT analyzed 1 h after the first sample. Patients with hemolysis with a hemoglobin concentration >0.1 g/dl, H-index >=100 in either the 0- or

1-h sample will be excluded. Clinical data and 1-h high sensitivity troponin T samples will be collected by research assistants. Further diagnostic testing and treatment will be performed, as in routine care, at the discretion of the responsible physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1167
• Est. completion date: April 30, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >=18 years of age

• Presented to the ED with non-traumatic chest pain/discomfort

• Hs-cTnT testing was ordered at presentation

Exclusion Criteria:

• STEMI at presentation

• Severe communication barriers

• Hemolysis with a hemoglobin concentration>0.1 g/dl, H-index>=100

Related Conditions & MeSH terms

• Chest Pain
• Diagnosis

Intervention

Diagnostic Test:
• High sensitivity troponin T
Collection of hs-cTnT samples

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

References & Publications (1)

Mokhtari A, Borna C, Gilje P, Tyden P, Lindahl B, Nilsson HJ, Khoshnood A, Bjork J, Ekelund U. A 1-h Combination Algorithm Allows Fast Rule-Out and Rule-In of Major Adverse Cardiac Events. J Am Coll Cardiol. 2016 Apr 5;67(13):1531-1540. doi: 10.1016/j.jacc.2016.01.059. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day MACE	MACE within 30 days including the index visit. MACE was defined as an adjudicated diagnosis of AMI, UA, cardiac arrest, cardiogenic shock, ventricular arrhythmia requiring intervention, atrioventricular block requiring intervention, or death of a cardiac or unknown cause	30 days
Secondary	30-day MACE without UA	Defined as an adjudicated diagnosis of AMI, cardiac arrest, cardiogenic shock, ventricular arrhythmia requiring intervention, atrioventricular block requiring intervention, or death of a cardiac or unknown cause	30 days