- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837535
Myocardial Infarction in the Perioperative Setting (MIPS)
Myocardial Infarction in the Perioperative Setting, a Swedish Multi Center Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden, 17176
- Karolinska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- Adults (≥18 years), male and female
- Undergoing elective or non-elective inpatient noncardiac surgery
Exclusion Criteria:
- Cardiac surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients undergoing surgery
Swedish patients, >18 years undergoing surgery 2007-2014
|
Neuro, Lung/thorax, GI, Gynecologic, Urologic, Orthopedic, Vascular surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 30days of the index surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Death, as detected in the postoperative phase in the Swedish cause of death register
|
Within 30days of the index surgery and at later predefined time points: 60, 90, 180 and 365 days after the index surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay (LOS)
Time Frame: LOS within the year after the index surgery
|
Time spent in the hospital (number of days)
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LOS within the year after the index surgery
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Days at home alive within 30 days (DAH30)
Time Frame: DAH30 is counted within 30days of the index surgery
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Time spent in the home after the index surgery, takes into account readmissions
|
DAH30 is counted within 30days of the index surgery
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Risk of AMI and Mortality by gender, type of surgery, extent- and recency of comorbidity
Time Frame: Within one year of the index surgery
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How above mentioned patient characteristics affect risk of AMI and mortality
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Within one year of the index surgery
|
Secondary complications
Time Frame: Secondary complications within one year of the index surgery
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AMI vs non-AMI patients and their risk of AKI, pneumonia, stroke, infections, thromboembolic complications
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Secondary complications within one year of the index surgery
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Outcomes (AMI+Mortality+Complications) by hospital, region and year
Time Frame: All outcomes within one year of the index surgery
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All outcomes as affected by hospital type, region and by year
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All outcomes within one year of the index surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karolinska UH_PR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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