NCT04614805

Brief Summary

The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration 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

October 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

October 18, 2020

Last Update Submit

January 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to reperfusion

    Interval between 1st medical contact and opening of the infarction-related coronary artery.

    This parameter will be recorded within 1 week after patient inclusion

Secondary Outcomes (2)

  • Ejection fraction at discharge

    This parameter will be recorded up to 6 months after patient inclusion

  • Survival

    This parameter will be collected from patient's records during Nov -20 till Aug -21.

Interventions

Clinical leaders and clinical personnel will regularly receive feedback regarding performance of their own hospital as well as other providers in the regional health trust of North Norway.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with STEMI in our regional health trust during the study period who has an indication for immediate reperfusion therapy

You may qualify if:

  • Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI)

You may not qualify if:

  • Reperfusion therapy not indicated or contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital North Norway

Tromsø, Troms Og Finnmark, 9038, Norway

Location

Related Publications (1)

  • Bartnes K, Albrigtsen H, Iversen JM, Brovold H, Moller NH, Wembstad B, Arstad F, Kristensen AH, Cortis J, Olsen SJ, Nygaard SNS, Kindler SG, Moe O, Hansen C, Mannsverk JT. The Barriers to Rapid Reperfusion in Acute ST-Elevation Myocardial Infarction. Cardiol Ther. 2022 Dec;11(4):559-574. doi: 10.1007/s40119-022-00281-7. Epub 2022 Oct 6.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Division of Cardiothoracic and Respiratory Medicine

Study Record Dates

First Submitted

October 18, 2020

First Posted

November 4, 2020

Study Start

November 1, 2020

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

January 6, 2023

Record last verified: 2023-01

Locations