The primary aim of this study is to assess the association of PMI pulmonary embolism. Additionally, the association between PMI and obstructive CAD will be investigated.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pulmonary embolism (PE) on either Coronary Computed Tomography Angiography
(CCTA) or Ventilation/Perfusion (V/Q) scan. PE on CCTA is defined as a sharply
delineated pulmonary artery filling defect in at least two consecutive image
sections of the CCTA, either located centrally within the vessel or with acute
angles at its interface with the vessel wall. PE on V/Q scan is defined as at
least one segmental or two subsegmental perfusion defects without corresponding
abnormality on chest X-ray.
Secondary outcome
1. Obstructive coronary artery disease, defined as > 50% stenosis in one or
more epicardial vessels on CCTA.
2. Incidence of obstructive (>50%) main stem or proximal left anterior
descending (LAD) stenosis.
3. Major adverse cardiovascular events within 30 postoperative days, which is
defined as the composite of cardiovascular death, non-fatal myocardial
infarction, non-fatal cardiac arrest, non-fatal ventricular fibrillation,
ventricular arrhythmia with hemodynamic compromise and cardiac
revascularisation (percutaneous coronary intervention (PCI) or coronary artery
bypass graft (CABG)) .
4. 30-day all-cause mortality
5. Major diagnostic change, which is defined as a clinically relevant change in
diagnosis after CCTA in comparison to the most likely diagnosis before CCTA.
The diagnosis prior to CCTA is made by the cardiology consultant and is based
on routine clinical care. This may include laboratory assessment, ECG, physical
examination and/or transthoracic echocardiography.
6. Major therapeutic change, which is defined as any change in in management of
patients as result of CCTA findings compared to the proposed treatment before
CCTA.
7. Safety endpoint: bleeding within one year after surgery, which is based on
TIMI criter
Background summary
Postoperative cardiac troponin has shown to be a strong and independent
predictor of mortality in a wide range of patients undergoing noncardiac
surgery. Such postoperative myocardial injury (PMI) is believed to be primarily
attributable to an oxygen supply / demand mismatch in the presence of
pre-existent coronary artery disease or - to a lesser extent - rupture or
fissure of an atherosclerotic carotid plaque. Yet, PMI may also be caused by
other factors such as pulmonary embolism, chronic renal insufficiency and
sepsis.
Study objective
The primary aim of this study is to assess the association of PMI pulmonary
embolism. Additionally, the association between PMI and obstructive CAD will be
investigated.
Study design
This is a prospective study in patients who undergo routine postoperative
troponin assessment after major (semi-)elective noncardiac surgery. Major
(semi-)elective noncardiac surgery is defined as all surgical procedures
requiring * 24 hours of hospital admittance that have been preceded by a
preoperative evaluation. Two groups (i.e. the PMI group and control group) are
created based on postoperative troponin levels. The *PMI group* will consist of
patients with postoperative troponin levels * 60 ng/L and the control group
will consist of patients with postoperative troponin levels < 60 ng/L (until
05-2018), after which a more sensitive essay was introduced: troponin-I, after
which te cut off value was 18 ng/L. Both groups will comprise 50% of the study
population
Study burden and risks
Study-related burden:
Study-related burden consists of a CCTA (or V/Q scan in a small proportion of
patients) during hospital admission, follow-up via telephone or face-to-face
contact at the outpatient clinic 4-8 weeks after surgery and a questionnaire
one year after surgery. The CCTA is relatively short, well tolerated by most,
and does not cause extension of hospital admittance. Previous experience with
postoperative CCTA in our hospital has shown that CTTA is a feasible scan after
operation. V/Q scan does not require contrast agents and is therefore a good
alternative for those patients who do not tolerate CCTA.
Study-related risks:
A minimal risk of a contrast nephropathy and/or an allergic reaction to the
contrast agent has to be recognized. A nephropathy is very rare in patients
with a normal kidney function. Patients with an impaired renal function or
known contrast allergy will undergo a V/Q scan instead of CCTA. No contrast
agents are used in V/Q scans, which makes it safe to use in patients with
impaired renal function. Radiation exposure associated with the CCTA is
approximately 9 mSv, which is comparable to 4 times the annual amount of
background radiation. Radiation exposure associated with V/Q scans is
approximately 2.6 mSv. As a consequence, the study is associated with a
negligible risk.
Initiation of anticoagulant therapy in case of a pulmonary embolism,
significant CAD, myocardial infarction, or cardiac dysrhythmia may lead to an
increased risk of postoperative bleeding. However, such additional treatment
belongs to daily clinical practice and is always based on current clinical
guidelines and only initiated after deliberation of the treating surgeon, a
cardiologist and/or a pulmonologist taking into account the clinical condition
of the patient.
Study-related benefit:
CCTA allows for direct visualization of the heart, coronary tree and adjacent
structures. Patients with significant CAD are therefore directed towards
adequate treatment * such as optimized medical treatment or coronary
revascularization therapy - in an earlier stage. In case of other relevant
(i.e. non-coronary) findings, the patient may also benefit from earlier
diagnosis and treatment.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
-* 60 years old
-Major noncardiac surgery, defined as non-cardiac surgical procedures requiring hospital admittance > 24 hours
-(Semi-)elective surgery, defined as surgery that that has been preceded by a preoperative evaluation.
-* 1 troponin assessment in the first 3 postoperative days as a part of the routine *postoperative troponin assessment* protocol.
-For patients who undergo surgery more than once, the first surgery will be included in the analysis. Reoperations will not be included.
Exclusion criteria
-Typical angina
-Acute ST-elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB) on ECG
-Patients unable to fully comply to study needs (e.g. incompetent patients or patients unable to communicate in Dutch or English)
-Severe claustrophobia.
-Patients who have a life expectancy of less than three months.
-Patients who are too ill to undergo a CCTA or Ventilation/Perfusion (V/Q) scan.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02682966 |
| CCMO | NL56699.041.16 |