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.
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
- Conditions the study is for
- Myocardial Infarction Postoperative, Myocardial Injury, Intraoperative Complications
- 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.
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:
- How common is perioperative acute myocardial infarction following non-cardiac surgery?
- What are the preoperative and intraoperative risk factors for peroperative AMI?
- Does perioperative AMI affect mortality and morbidity, Length of stay and days at home?
- 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.
- Conditions
- Myocardial Infarction Postoperative, Myocardial Injury, Intraoperative Complications, Intraoperative Hypotension, Peroperative Complication
- 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 group | Role | What they receive |
|---|---|---|
| Patients undergoing surgery | Swedish 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.
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)
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.
- First posted12 Feb 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bell, Karolinska University Hospital
- Investigators
- Max Bell, MD, PhD, Principal investigator, Karolinska University Hospital, Karolinska Institutet
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Infarction in the Perioperative Setting, a Swedish Multi Center Cohort Study
- ClinicalTrials.gov ID
- NCT03837535
- Acronym / sponsor ID
- MIPS / Karolinska UH_PR
- Conditions
- Myocardial Infarction Postoperative, Myocardial Injury, Intraoperative Complications, Intraoperative Hypotension, Peroperative Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,742 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- How common is perioperative acute myocardial infarction following non-cardiac surgery?
- What are the preoperative and intraoperative risk factors for peroperative AMI?
- Does perioperative AMI affect mortality and morbidity, Length of stay and days at home?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery | – | Procedure: SurgerySwedish patients, >18 years undergoing surgery 2007-2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Adults (≥18 years), male and female
- Undergoing elective or non-elective inpatient noncardiac surgery
Key exclusion criteria (1 listed)
- Cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryNeuro, Lung/thorax, GI, Gynecologic, Urologic, Orthopedic, Vascular surgery | Procedure or surgery | Patients undergoing surgery |
Primary outcome
Acute Myocardial Infarction
Time frame: Within 30days of the index surgery
AMI, as detected in the postoperative phase in the electronic medical records or in the Swedeheart registry
1 secondary outcome
Mortality
Time frame: Within 30days of the index surgery and at later predefined time points: 60, 90, 180 and 365 days after the index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Yes. De-identified cohort data for primary and secondary endpoints will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Bell, MD, PhD principal investigator
Karolinska University Hospital, Karolinska Institutet
1 site in 1 country: see every site and its status.
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.