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Myocardial Infarction PostoperativeMIPSNCT03837535

Myocardial Infarction in the Perioperative Setting

An observational study of Myocardial Infarction Postoperative and Myocardial Injury, run by Karolinska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surgery
Type of treatment
Surgery or procedure
How many people
400,742 participants
Where
1 siteSweden
Study dates
1 Jan 2019to 31 Dec 2019
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Cardiac surgery

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: Myocardial Infarction in the Perioperative Setting, a Swedish Multi Center Cohort Study

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.

Read the detailed description

Background:

In Sweden, over 800 000 patients undergo surgery each year. Worldwide, the number of surgical procedures yearly is over 310 million. Surgical care is an essential part of the advancement in treating disease, associated with increased life expectancy and improved quality of life. However, as surgical volume continues to grow, the number of patients who suffer postoperative complications will also increase.

More specifically the project aims to answer the following questions:

  1. How common is perioperative acute myocardial infarction following non-cardiac surgery?
  2. What are the preoperative and intraoperative risk factors for peroperative AMI?
  3. Does perioperative AMI affect mortality and morbidity, Length of stay and days at home?
  4. Is the risk of AMI affected by the type of hospital, region or calendar year of surgery?

Orbit - surgical planning system:

The study population was identified from 23 hospitals of all levels (university-, County- and district hospitals) in Sweden, that use the same software program to administer surgical procedures, between 1999 and 2015. The Orbit surgical planning system obligatory includes Swedish identity number, patient demographics, elective or non-elective status, date, type, extent and duration of anesthesia and surgery. Information of the American Society of Anesthesiologists (ASA) physical status classification was often available.

National Patient Register:

To obtain information on discharge dates, covariates and drug exposure, records of surgeries will be linked to the national patient register using the unique Swedish personal identification number assigned to all at birth or at immigration. The national registers have close to complete coverage. The Swedish cause of death registry includes the deaths of all Swedish citizens and residents with a national identity number; it is highly reliable with over 99% of all deaths reported. The Swedish Prescribed Drug Register became operational in July 2005 and contains data on all dispensed prescription of drugs in the Swedish population.

Swedeheart:

To identify all incident cases of myocardial infarctions, the surgical cohort will be linked to Swedeheart, a National Quality Registry containing data on all patients with acute myocardial infarction and all patients undergoing angiographic coronary intervention and heart surgery. The Swedeheart registry was developed in January 1995 and has a present coverage of 95% among incident cases of myocardial infarction treated at a cardiology department.

The National Board of Health and Welfare:

The National Board of Health and Welfare publishes statistics in the areas of health and medical care and social services, including data on acute myocardial infarction. The statistics include all persons aged 20 years and above who have had an acute myocardial infarction reported at the Hospital Discharge Register or the Cause of Death Register. Statistics are presented by year, sex, age and geographical area, information of incidence per 100 000 inhabitants is provided. These data were used to obtain information of expected cases of MI, for standardized incidence ratios (SIR) to be calculated.

Study Participants:

Patients aged 18 years or older undergoing elective or non-elective inpatients surgery between January 1, 2007 and December 31, 2014 were included. Exclusion criteria were surgeries in ambulatory care, cardiac surgery, obstetric- and minor surgical procedures. Patients were also excluded if the surgery was performed prior to 2007 or after 2014, and if a valid surgery code in Orbit - or if a corresponding surgery code in NPR - was lacking.

Being tested
Surgery
Medical subject headings
Intraoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

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

Study groups in NCT03837535
Study groupRoleWhat they receive
Patients undergoing surgerySwedish patients, >18 years undergoing surgery 2007-2014
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Myocardial Infarction

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

    Measured: Within 30days of the index surgery

Secondary outcomes (1)
  1. Mortality

    Death, as detected in the postoperative phase in the Swedish cause of death register

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400,742 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03837535
Sponsor's protocol ID
Karolinska UH_PR
Acronym
MIPS
Status last verified
Feb 2020
First submitted
7 Feb 2019
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified cohort data for primary and secondary endpoints will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction Postoperative and Myocardial Injury, run by Karolinska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Myocardial Infarction (time frame: Within 30days of the index surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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