Myocardial Infarction in the Perioperative Setting

NCT03837535 | Completed

• 1 other identifier: Karolinska UH_PR
• Study Type: observational
• Target: 400,742
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Infarction Postoperative; Myocardial Injury; Intraoperative Complications; Intraoperative Hypotension; Peroperative Complication

Outcome Measures

Primary Outcomes (1)

• Acute Myocardial Infarction

  AMI, as detected in the postoperative phase in the electronic medical records or in the Swedeheart registry

  Within 30days of the index surgery

Secondary Outcomes (1)

• Mortality

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

Other Outcomes (5)

• Length of stay (LOS)

  LOS within the year after the index surgery

• Days at home alive within 30 days (DAH30)

  DAH30 is counted within 30days of the index surgery

• Risk of AMI and Mortality by gender, type of surgery, extent- and recency of comorbidity

  Within one year of the index surgery

Study Arms (1)

Patients undergoing surgery

Swedish patients, \>18 years undergoing surgery 2007-2014

Procedure: Surgery

Interventions

Surgery PROCEDURE

Neuro, Lung/thorax, GI, Gynecologic, Urologic, Orthopedic, Vascular surgery

Patients undergoing surgery

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

Adult patients undergoing non-cardiac surgery between 2007 and 2014 in Swedish Hospitals using the Orbit software surgical planning tool. This software system is used in all parts of Sweden and in all types of hospitals (University, County and District hospitals) * University hospitals: Huddinge, KS, Norrlands universitetssjukhus, MAS, USIL, \*\* County hospitals: NU-sjukvården, Sundsvalls, Södra Älvsborgs, Örnsköldsviks \*\*\* District hospitals: Helsingborgs lasarett, Hässleholms, Kristanstads, Kullbergska, Landskrona, Lycksele, Mälarsjukhuset, Nyköping, Sollefteå, Skellefteå Södertälje, Trelleborg, Ystad, Ängelholm, Privat Ortopedisk klinik

You may qualify if:

• Adults (≥18 years), male and female
• Undergoing elective or non-elective inpatient noncardiac surgery

You may not qualify if:

• Cardiac surgery

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Intraoperative Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Max Bell, MD, PhD

  Karolinska University Hospital, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• 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: February 7, 2019
• First Posted: February 12, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within a year of study completion
• Access Criteria: Data access will be reviewed by an external research committee at the department of perioperative medicine and intensive care at the Karolinska University Hospital

Locations

SE (1)