Myocardial Injury Following Non-cardiac Surgery (EMINENT)
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|ClinicalTrials.gov Identifier: NCT03317561|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : February 20, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|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|
Subjects who have had an increase in troponin T level (> 99 percentile) in the perioperative period shall form the cases.
Subjects who do not have an increase in troponin T level (< 99 percentile) in the perioperative period shall form the controls.
- 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)
- Protocolized echocardiography [ Time Frame: < 48 hours after rise in Troponin T ]Determination of wall motion abnormalities and systolic and diastolic function.
- 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)
- 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
- 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
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
|Contact: Anil Gupta, MD, PhD||08-5170000 ext email@example.com|
|Contact: Marja Lindqvist, MD, PhD||08-5170000 ext firstname.lastname@example.org|
|Principal Investigator:||Anil Gupta, MD, PhD||Department of Clinical Research, and PMI, Karolinska Hospital|