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Trial record 1 of 3 for:    michelle chew
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Myocardial Injury in Noncardiac Surgery in Sweden (MINSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436238
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : September 7, 2020
Sponsor:
Collaborators:
Region Östergötland
Medical Research Council of Southeast Sweden
Information provided by (Responsible Party):
Michelle Chew, Linkoeping University

Tracking Information
First Submitted Date February 10, 2018
First Posted Date February 19, 2018
Last Update Posted Date September 7, 2020
Actual Study Start Date May 15, 2017
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 10, 2018)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 10, 2018)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 10, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Myocardial Injury in Noncardiac Surgery in Sweden
Official Title Myocardial Injury in Noncardiac Surgery in Sweden (MINSS) Study: Multi-centre, Observational Cohort Study of Patients Undergoing Elective, Major Abdominal Surgery.
Brief Summary The purpose of this multicentre, prospective, observational study is to identify robust biochemical markers that predict adverse cardiovascular outcomes and mortality in patients undergoing major abdominal surgery.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Patients scheduled for elective, major abdominal surgery at participating centres, requiring general anaesthesia, and requiring at least one overnight stay.
Condition
  • Perioperative/Postoperative Complications
  • Risk Factor, Cardiovascular
Intervention Not Provided
Study Groups/Cohorts MINSS cohort

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).

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 3, 2020)
1269
Original Estimated Enrollment
 (submitted: February 10, 2018)
1600
Estimated Study Completion Date December 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients undergoing elective, major abdominal surgery*.

(*Major abdominal surgery requiring general anaesthesia, and requiring at least one overnight stay. Major abdominal surgery is defined as those classified as major OR major/complex by the Surgical Outcome Risk Tool (SORT) (www.sortsurgery.com).

In essence major surgery is one that penetrates and exposes a body cavity or produces a substantial impairment of physical or physiologic function or involves extensive dissection or transection. Examples of a major abdominal surgery include, but are not limited to, any procedure involving a laparotomy or laparoscopic procedures of the stomach, duodenum, small and large intestine and rectum. It also includes but is not limited to procedures on the reproductive system (total abdominal hysterectomy, salpingo-oophorectomy) and genitourinary system (nephrectomy, cystectomy).)

Exclusion Criteria:

  • Patient not fulfilling inclusion study criteria above and/or clinician refusal and/or non-eligible as defined below.

Patients undergoing the following surgical procedures will NOT be eligible:

  • transplantation
  • trauma
  • endocrine
  • vascular
  • endovascular

The presence of any one of the following will also lead to exclusion of the patient:

  • ACS at presentation (clinical assessment or documentation)
  • New or decompensated congestive heart failure at presentation (clinical assessment or documentation)
  • Documented severe aortic stenosis (valve area < 1cm2)
  • Reduced LVEF (<40%); if no LVEF is available, it will be assumed to be >40%
  • Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03436238
Other Study ID Numbers MINSS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Michelle Chew, Linkoeping University
Study Sponsor Linkoeping University
Collaborators
  • Region Östergötland
  • Medical Research Council of Southeast Sweden
Investigators
Principal Investigator: Michelle S Chew, MBBS, PhD Linkoeping University and Region Östergötland
PRS Account Linkoeping University
Verification Date September 2020