NCT03974321

Brief Summary

Acute myocardial infarction (MI) is a significant complication following non-cardiac surgery. We sought to evaluate incidence of perioperative MI, its preoperative - and intraoperative - risk factors and outcomes after this complication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 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

Study Start

First participant enrolled

May 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

June 2, 2019

Last Update Submit

October 23, 2020

Conditions

Myocardial Infarction PostoperativeMyocardial InjuryIntraoperative ComplicationsIntraoperative HypotensionPerioperative Complication

Outcome Measures

Primary Outcomes (1)

  • Acute Myocardial Infarction

    Acute MI, detected in the postoperative phase in the electronic medical records or in the Swedeheart Registry

    Within 30 days after the index surgery

Secondary Outcomes (1)

  • Mortality

    Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.

Eligibility Criteria

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

Adult patients undergoing non-cardiac surgery between 2007 and 2014 at 3 Swedish University hospitals; Karolinska University hospital, Skåne University Hospital and Norrland University hospital.

You may qualify if:

  • Adults (≥18 years), male and female.
  • Undergoing elective or non-elective in-patients non-cardiac surgery at 3 University Hospitals in Sweden: Karolinska University hospital, Skåne University hospital and Norrland University hospital.
  • Surgeries performed between 2007 and 2014.
  • Acute myocardial infarction criteria fulfilled within 30 days after surgery.

You may not qualify if:

  • Cardiac surgery
  • Obstetric surgery
  • Controls:
  • Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Max Bell, MD, PhD

    Karolinska University Hospital, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor, Senior Lecturer

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 4, 2019

Study Start

May 1, 2019

Primary Completion

June 15, 2019

Study Completion

March 30, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Locations

SE(1)