Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05860504 |
Other study ID # |
SCCCS |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 29, 2023 |
Est. completion date |
March 30, 2026 |
Study information
Verified date |
October 2023 |
Source |
Sahlgrenska University Hospital, Sweden |
Contact |
Jonatan Oras, MD, PhD |
Phone |
+46313421000 |
Email |
jonatan.oras[@]vgregion.se |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The overall aim of the study is to establish the clinical importance of cardiac dysfunction,
by estimating its incidence and impact on short- and long-term outcomes, in a mixed
population of critically ill patients with multi-organ failure. Pathogenesis of cardiac
dysfunction in critical illness and key molecules linked to this will be explored.
Description:
During critical illness, the heart is exposed to extreme external stressors, which may
contribute to heart failure. There is a lack of knowledge of what happens to the heart over
the course of critical illness. The few studies available suggest that LV dysfunction is
common in critical illness, with a prevalence of 10-30%. Notably, LV regional hypokinesia is
a frequent pattern of LV dysfunction among these patients and is associated with a higher
risk of death.
LV regional hypokinesia during critical illness may have several possible aetiologies,
including ischemic, inflammatory or other/mixed processes. Of these, acute coronary artery
obstruction is probably most important. Patients with sepsis, for example, and acute ST
elevation myocardial infarction have twice the risk of death. Type II myocardial infarction
can also lead to LV dysfunction due to insufficient coronary artery flow e.g., from
tachycardia, hypotension and hypoxia, resulting in myocardial ischemia. In the absence of
CAD, LV regional hypokinesia could also result from myocardial inflammation secondary to
systemic inflammatory response, direct toxic effects of cytokines or pathogenic infiltration.
Another possible aetiology is Takotsubo syndrome, an acute cardiac condition characterised by
reversible regional hypokinesia, usually in the apical portion of the LV. The current
paradigm suggests that Takotsubo syndrome is triggered by the overstimulation of the
myocardium by catecholamines and is closely correlated to events involving severe emotional
or physical stress. Cardiac dysfunction in critical illness is likely a phenotype of
Takotsubo syndrome since patients in the ICU undergo extreme stress and are exposed to both
endogenously-released and exogenously-administered catecholamines.
In critical illness, accurate diagnosis of LV dysfunction is challenging due to the similar
clinical presentation of potential aetiologies. However, diagnosing the underlying aetiology
of LV dysfunction is essential to provide appropriate treatment and optimise outcomes. CAD
can be diagnosed with coronary angiography and cardiac computed tomography (CCT). In the
absence of CAD, cMRI is useful. cMRI can differentiate between myocardial ischemia, and
inflammation, as well as between an acute or past event.
In this study, patients are examined with echocardiography to identify those with cardiac
dysfunction. In a sub-set of patients with LV dysfunction, patients will be examined with
coronary CT (if no angiography performed) and cardiac MRI. Blood samples are collected for
storage in biobank.