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Myocardial Injury Following Non-cardiac Surgery (EMINENT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317561
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Anil Gupta, Karolinska Institutet

Brief Summary:

It is estimated that > 200 million patients in the world undergo surgery each year of which approximately 10 million will suffer from a myocardial injury in the perioperative period. Mortality is high in patients with myocardial injury since it often goes undiagnosed and management is unclear. In contrast to myocardial infarction diagnosed in the emergency room (non-surgical patient) where treatment is well established today, patients suffering from a perioperative myocardial injury have a poorer outcome. Additionally, the patho-physiology of myocardial injury is unknown in the individual patient, non-invasive diagnostic tools are not widely available and treatment remains unknown.

Most cases of myocardial injury in Non-cardiac surgery (MINS) are seen within the first 48-72 h after surgery and a majority have no symptoms. Many patients developing MINS are < 65 years old and non-diabetics, an age group that usually does not have coronary artery disease. A elevated Troponin T (TnT) without symptoms or ECG changes, typically occurring in the perioperative period, is an independent predictor of 30-day mortality. Surgical trauma also causes an increase in several pro-inflammatory cytokines, which together with sympathetic over-activity and platelet activation, leads to a hyper-coagulant state, and in turn may cause coronary thrombosis. It is possible that some cases of MINS also result from oxygen supply-delivery mismatch. To our knowledge, no study has investigated the cause of MINS in patients presenting with increased TnT in the perioperative period. Our aim is therefore to investigate patients having MINS in order to better understand its aetiology and subsequently develop focused strategies to reduce risks.


Condition or disease
Myocardial Injury Surgery--Complications

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Etiology of Myocardial Injury Following Non-cardiac Surgery - a Prospective Clinical Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
Myocardial injury
Subjects who have had an increase in troponin T level (> 99 percentile) in the perioperative period shall form the cases.
Control
Subjects who do not have an increase in troponin T level (< 99 percentile) in the perioperative period shall form the controls.



Primary Outcome Measures :
  1. Coronary artery obstruction [ Time Frame: < 1 week after rise in Troponin T ]
    Number of patients with a significant coronary artery stenosis (>50%) in one or more of the arteries as measured by CT angiography (CTA)


Secondary Outcome Measures :
  1. Protocolized echocardiography [ Time Frame: < 48 hours after rise in Troponin T ]
    Determination of wall motion abnormalities and systolic and diastolic function.

  2. Lung embolism [ Time Frame: < 1 week after rise in Troponin T ]
    Evidence of lung embolism as determined by CT angiography (Examinations will be performed on a 64-slice CT scanner)

  3. Platelet microparticles (PMP) [ Time Frame: < 3 days after rise in Troponin T ]
    Increased concentration of PMPs characteristic of platelet activation will be measured in the laboratory

  4. Calcium score [ Time Frame: < 1 week following a rise in TnT ]
    A calcium score of > 75:e percentile (in relation to patients age and gender)


Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an increase in Troponin T (> 14 ng/L) after induction of anesthesia will form the Myocardial injury Group while those without an increase in Troponin T (< 14 ng/L) will form the Control group
Criteria

Inclusion Criteria:

  1. Patients in the age group 45-70 years
  2. Major, non-cardiac surgery

Exclusion Criteria:

  1. Patients with atrial fibrillation
  2. Moderate-severe renal insufficiency (GFR < 50)
  3. Allergy to iv contrast will be excluded
  4. Patients with a preoperative rise in Troponin T
  5. Known lung embolism
  6. Known deep vein thrombosis (DVT)
  7. Inability to comprehend the study or language barriers

Information from the National Library of Medicine

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): NCT03317561


Contacts
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Contact: Anil Gupta, MD, PhD 08-5170000 ext 70387 anil.gupta@sll.se
Contact: Marja Lindqvist, MD, PhD 08-5170000 ext 75812 marja.lindqvist@sll.se

Locations
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Sweden
Karolinska Hospital, Solna Recruiting
Stockholm, Sweden, 17176
Contact: Anna Grannström, BSc    08-5170000 ext 74416    anna.grannstrom@sll.se   
Contact: Anna Schening, BSc    08-5170000 ext 74416    anna.schening@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Principal Investigator: Anil Gupta, MD, PhD Department of Clinical Research, and PMI, Karolinska Hospital
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Responsible Party: Anil Gupta, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03317561    
Other Study ID Numbers: 2017-11-01
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned as of today

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anil Gupta, Karolinska Institutet:
troponin
major surgery
Additional relevant MeSH terms:
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Wounds and Injuries