NCT04280926

Brief Summary

Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

December 17, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

January 23, 2020

Last Update Submit

December 16, 2024

Conditions

Acute Myocardial InfarctionAcute Coronary Syndrome

Keywords

Troponinhigh-sensitivity cardiac troponinacute myocardial infarctionSiemens Atellica

Outcome Measures

Primary Outcomes (3)

  • Incidence of acute myocardial infarction - Abbott hs-cTnI

    Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay

    Day 1

  • Incidence of myocardial infarction - Roche Gen 5 cTnT

    Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay

    Day 1

  • Incidence of myocardial infarction - Abbott contemporary cTnI

    Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay

    Day 1

Secondary Outcomes (6)

  • All-cause mortality

    up to 180 days

  • Cardiac mortality

    up to 180 days

  • Adjudicated index acute myocardial infarction according to 4th UDMI

    on admission

  • Number of participants that underwent revascularization

    up to 180 days

  • Safety Outcome - MACE

    30 days

  • +1 more secondary outcomes

Study Arms (1)

Cohort

Study population: Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.

Diagnostic Test: Cardiac Troponin Testing

Interventions

Cardiac Troponin TestingDIAGNOSTIC_TEST

Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutives patients (goal, 2000 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.

You may qualify if:

  • Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
  • At least one 12-lead electrocardiogram

You may not qualify if:

  • Less than 18 years old
  • Pregnancy
  • Trauma
  • Decline to participate
  • Did not present through the ED
  • Transferred from an outside hospital or clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • Fabre-Estremera B, Smith SW, Sandoval Y, Schulz K, Okeson B, Cullen L, Apple FS. Rapid Rule-Out of Myocardial Infarction Using a Single High-Sensitivity Cardiac Troponin I Measurement Strategy at Presentation to the Emergency Department: The SAFETY Study. Clin Chem. 2023 Jun 1;69(6):627-636. doi: 10.1093/clinchem/hvad033.

    PMID: 37022774DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess blood is biobanked after clinical testing for cTnI

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Fred S Apple, PhD

    Hennepin Healthcare Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

February 21, 2020

Study Start

October 13, 2020

Primary Completion

October 13, 2021

Study Completion

October 13, 2024

Last Updated

December 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)