Myocardial Injury in Noncardiac Surgery in Sweden (MINSS)
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|ClinicalTrials.gov Identifier: NCT03436238|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : September 7, 2020
|Condition or disease|
|Perioperative/Postoperative Complications Risk Factor, Cardiovascular|
Inclusion Adults at least 50 years old undergoing elective, major or major/complex abdominal surgery defined according to the Surgical Outcome Risk Tool (www.sortsurgery.com), requiring general anaesthesia and at least one overnight stay. Exclusion Patients with acute coronary syndromes, new or decompensated heart failure at presentation, documented severeaortic stenosis, severely reduced ejection fraction (<40%) and inability to follow the procedures of the study or lack of capacity to give informed consent. Transplantation, trauma, endocrine, vascular and endovascular surgical procedures will also be excluded due to their distinct risk profiles compared with the intended population. Outcome The composite endpoint is all-cause mortality at 30 days and MACCE, the latter defined as nonfatal cardiac arrest, acute MI, congestive heart failure, new cardiac arrhythmia, angina and stroke. Secondary endpoints are 365-day all-cause mortality and MACCE. Data collection Relevant clinical and peri-operative data for example comorbidities, RCRI, ASA-PS score, type and length of surgery, blood loss and intra-operative lowest blood pressure will be collected.
Plasma levels of hsTnT, NTproBNP, Copeptin, MR-proADM and CT-proET1 will be measured at five sampling points: pre-operatively, immediately postoperatively, and on Days 1 to 3 postoperatively or until discharge. Data on MACCE will be obtained from patient records and structured telephone interviews at 30 and 365 days by assessors blinded to the results of the biomarker analyses.
Statistics Based on an assumed incidence of MINS of 10%(1) and 365-day mortality in the non-MINS group of 11% (estimate based on current data from the Swedish Perioperative Registry), the required sample size to detect an effect size of 10% is 1142. To account for drop-outs and missing data, we will recruit up to 1600 patients.
Receiver operating curve analysis will be used to determine the optimal threshold of each biomarker in predicting mortality/MACCE. The net reclassification index will be used to assess if biomarkers confer added value to the RCRI for the classification of MACCE.
A multivariable Cox proportional hazard models will be used to test the independent prognostic value of biomarkers. The sample size allows for adjustment of the following prespecified variables, selected on the basis of clinical plausibility and prior evidence: age, sex, ASA-PS class, RCRI, Charlson Comorbidity Index, length and type of surgery, presence of intra-operative hypotension, pre-operative creatinine and haemoglobin, biomarkers (alone and in combination). An independent statistical analysis will be conducted after recruitment of 600 patients to assess the frequency of outcomes and missing data, after which the sample size may be adjusted.
NOTE: An independent assessment by the Data Safety and Monitoring Board (DSMB) specifically addressing a revision of the sample size found that a total of 1269-1334 participants would be required for the study. This was based on a lower than expected rate of missing data (7.6% at DSMB assessment vs. expected 33% during study planning).
We therefore revised the sample size to 1269 (-1334) participants on 2 September 2019.
|Study Type :||Observational|
|Actual Enrollment :||1269 participants|
|Official Title:||Myocardial Injury in Noncardiac Surgery in Sweden (MINSS) Study: Multi-centre, Observational Cohort Study of Patients Undergoing Elective, Major Abdominal Surgery.|
|Actual Study Start Date :||May 15, 2017|
|Actual Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Adult patients >= 50 years old undergoing elective, major, abdominal surgery requiring at least one overnight stay in hospital.
Major abdominal surgery is defined as those classified as major OR major/complex by the Surgical Outcome Risk Tool (SORT) (www.sortsurgery.com).
- 30-day mortality [ Time Frame: 30 days post surgery ]All-cause mortality at 30 days post-surgery.
- 30-day MACCE [ Time Frame: 30 days post surgery ]Major adverse cardio- cerebrovascular events (MACCE) at 30 days post-surgery.
- 12-month mortality [ Time Frame: 12 months post surgery ]All-cause mortality at 12 months post-surgery.
- 12-month MACCE [ Time Frame: 12 months post surgery ]Major adverse cardio- cerebrovascular events (MACCE) at 12 months post-surgery.
- Net reclassification index (NRI) [ Time Frame: 30 days post surgery ]The NRI will be calculated to assess if a preoperative elevated biomarker panel confers added value over RCRI
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436238
|Kristianstad KRYH Hospital|
|Kristianstad, Skåne, Sweden|
|Karolinska University Hospital Huddinge|
|Ryhov County Hospital|
|Skane University Hospital Lund|
|Skane University Hospital Malmö|
|Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland|
|Linköping, Östergötland, Sweden, 50185|
|Principal Investigator:||Michelle S Chew, MBBS, PhD||Linkoeping University and Region Östergötland|