This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Incidence, Patient Characteristics, Pathophysiology, and Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery (BASEL-PMI)

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02573532
First received: October 1, 2015
Last updated: October 11, 2016
Last verified: October 2016
  Purpose
This observational study includes patients undergoing major non-cardiac surgery, and screens them for the occurence of perioperative myocardial injuries (PMI). Incidence, patient characteristics, pathophysiology, and 1-year outcomes of PMI will be described.

Condition
Perioperative Myocardial Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Basel Incidence, Patient Characteristics, Outcome and Possible Strategies to Improve Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery: 1-Year Follow-up

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Deaths in one year after non-cardiac surgery in patients with and without PMI [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • MACE in one year after non-cardiac surgery in patients with and without PMI [ Time Frame: 1 year ]
    MACE is defined as a composite of death, acute myocardial infarction, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV) -block III), or acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit) within one year. Two independent cardiologists or anaesthesiologists will adjudicate all MACE.

  • Incidence of PMI within a screening program in high-risk patients undergoing major non-cardiac surgery [ Time Frame: 3 days after surgery ]
    PMI is defined two cardiac troponin T measurements with a delta of >=+14 ng/L PMI will be further classified as type I myocardial infarction, type II myocardial infarction, or myocardial injury due to non-cardiac causes

  • Number of patients with PMI with ischemic symptoms and signs detected in a screening program in high-risk patients undergoing major non-cardiac surgery [ Time Frame: 3 days after surgery ]
    Patients with PMI are evaluated for: presence of chest pain, atypical symptoms, palpitations, dyspnea, edema, or nausea; ST-changes, Q-waves, T-wave abnormalities, new bundle branch block

  • Number of patients with PMI with management changes after screening-induced consultation [ Time Frame: 3 days after surgery, followed for 1 year ]
    Changes in management can be: changes in medication, intensification of surveillance, call for use of coronary angiography, myocardial stress testing, other, or none

  • Generate a pre- and an immediate postoperative prediction score for occurrence of major adverse cardiac events including PMI [ Time Frame: 1 year ]
  • Costs related to the introduction of perioperative hs-cTnT screening. [ Time Frame: 1 year ]
    Health system costs of implementation of screening is calculated as number of interventions initiated additionally to routine care after screening


Other Outcome Measures:
  • Estimate potential effect of detection and management of PMI on major adverse cardiac events by a screening program implemented within clinical routine [ Time Frame: 1 year ]
  • Compare cardiac troponin T and I in the detection of PMI [ Time Frame: 3 days after surgery ]

Estimated Enrollment: 2000
Study Start Date: October 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Background: Worldwide more than 230 million surgical operations are performed each year. Despite advances in all fields of medicine, there is still a significant risk of death related to major non-cardiac surgical procedures. The observed 30-day mortality depends on patient- as well as procedural factors and ranges between 1% and 10%. Cardiovascular complications, particularly perioperative myocardial injury/infarction (PMI) seem to be major contributors to about a third of all deaths. PMI may differ from spontaneous acute myocardial infarction (AMI). The vast majority of patients experiencing PMI do NOT have acute chest pain or other symptoms typical for AMI likely because they are narcotized or sedated and random ECGs are often not informative. Accordingly, most patients with PMI are currently not detected in routine clinical practice. Missed diagnosis is invariably associated with missed opportunity for the initiation of treatment. As most patients with PMI are missed in routine clinical care, the true incidence of and outcome after PMI are largely unknown. Prior studies have often not obtained a baseline sample and thus have suggested that all cTn elevations are likely due to AMI which may exaggerate the numbers. In addition, usually conventional less sensitive assays have been used. Further, the predominant pathophysiology of PMI is currently unknown. It has been suggested that type II MI characterized by coronary perfusion pressure mismatch and not type I MI characterized by acute thrombotic coronary occlusion is the predominate mechanism. However, autopsy data suggest that plaque rupture is more common. Thus, it may be that type 2 AMI is more common but that the modest incidence of type 1 AMI is not dangerous prognostically.

Aim: To explore the incidence, patient characteristics, pathophysiology, and long-term outcome of PMI after major non-cardiac surgery

Methodology: 2000 consecutive high-risk patients undergoing major non-cardiac surgery will be included and followed for one year for the occurrence of all-cause death and other major adverse cardiac events. Patients receive a standardized assessment of cardiovascular status and systematic perioperative screening for PMI using high sensitivity cardiac troponin T (hs-cTnT) at baseline prior to surgery, as well as on day 1 and day 2 after surgery Acute cardiac injury will be defined as an absolute increase (+Δ) of hs-cardiac troponin (cTnT) of ≥14ng/L compared to baseline. A search for possible alternative causes for hs-cTnT elevations will be aggressively sought if a rising pattern of values is detected. Two independent experts will adjudicate the most likely cause of PMI using all clinical information pertaining to the individual patient including the 12-lead ECG, peak hs-cTnT blood concentrations, coronary angiography and myocardial perfusion scanning. Influence of PMI on occurrence of all-cause death will be assessed using multivariate Cox- proportional hazards analysis. Further, pre-operative and post-operative prediction models for death, major adverse cardiac events, and PMI shall be derived using a derivation-validation design.

Potential Significance: This study will generate scientific data that have major scientific implications by contributing to closing current knowledge gaps concerning the influence of PMI on long-term mortality as well as the incidence, patient characteristics, and pathophysiology of PMI after non-cardiac surgery. This knowledge will have immediate clinical implications as it could e.g. lead to major changes in perioperative management with reconsiderations of the necessary target blood pressure to avoid coronary perfusion mismatch and consecutive cardiac injury.

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients that underwent a systematic approach to PMI detection at University Hospital Basel, a tertiary care center, will be included.

The screening consists of a pre-operative "baseline" measurement of hs-cTnT within 30 days prior to surgery, and two post-operative measurements taken on the first and second day after surgery. Screening is done in patients requiring hospitalization >24 hours after surgery AND (aged ≥ 65 years OR history of coronary artery disease OR peripheral artery occlusive disease OR cerebrovascular disease). Patients are seen by a cardiologist in case of detection of a PMI.

Criteria

Inclusion criteria

  • Patients received a perioperative hs-cTnT screening for PMI
  • Patient consent available Exclusion criteria
  • Patient's refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02573532

Contacts
Contact: Christian Müller, MD +41 61 328 6549 christian.mueller@usb.ch
Contact: Christian Puelacher, MD +41 61 556 5830 christian.puelacher@usb.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, BS, Switzerland, 4031
Contact: Christian Müller, MD    +41 61 328 6549    christian.mueller@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christian Müller, MD University Hospital, Basel, Switzerland
Principal Investigator: Giovanna Lurati-Buse, MD, MPH University Hospital, Basel, Switzerland
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02573532     History of Changes
Other Study ID Numbers: BASEL-PMI
Study First Received: October 1, 2015
Last Updated: October 11, 2016

Keywords provided by University Hospital, Basel, Switzerland:
myocardial ischemia/diagnosis
myocardial ischemia/epidemiology
perioperative
perioperative complications/diagnosis
prognosis

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on June 28, 2017