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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03974321
Other study ID # 20180713
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date March 30, 2020

Study information

Verified date October 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Background: In Sweden, over 800 000 patents undergo surgery each year. Worldwide, the number of surgical procedures yearly is over 310 million. Surgical care is en essential part of the advancement in treating disease, associated with increased lift expectancy a d improved quality of life. However as surgical volume continues to grow, the number of patients who suffer postoperative complications will also increase. Hemodynamic instability in the perioperative period is frequent and there has been a cumulative interest in this area and the relation to organ failure over the recent years. There are several studies showing results of associations between intraoperative hypotensive events and perioperative cardiac, kidney and cerebral injury, as well as increased mortality in high-risk surgical patients. More specifically the project aims to answer how intraoperative events, with a special focus on hypotension, are related to perioperative myocardial and kidney injury. We hypothesize that patients, with preoperative risk factors, undergoing major non-cardiac surgery are at increased risk of developing perioperative organ damage in the presence of intraoperative hypotension or other events such as tachycardia, hypoxia and extensive blood loss.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date March 30, 2020
Est. primary completion date June 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Cases Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mortality Death, detected in the postoperative phase in the Swedish Cause of Death Register. Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.
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