Acute Cardiac Dysfunction in Critical Illnes

Myocardial Infarction Clinical Trial

Official title:

Aetiology and Clinical Importance of Acute Cardiac Dysfunction in Critical Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860504
• Other study ID #: SCCCS
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 592
• Est. completion date: March 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged > 18 years

2. Admitted to a participating ICU within 24 hours

3. Significant organ dysfunction involving at least two organ systems. This is defined as

fulfilling both of the following:

• At least 4 points on the SOFA scale (Sequential Organ Failure Assessment scale)
• Having at least 1 point on the SOFA scale from at least two organ systems

4. Given informed consent from patient or permission to participate from next of kin

Exclusion Criteria:

1. Echocardiographic examination not possible (e.g., pneumothorax, draping etc) or very low echocardiographic examination quality

2. Not being examined with echocardiography within 24 hours from inclusion

3. Retracted consent to participate

Related Conditions & MeSH terms

• Cardiomyopathies
• Infarction
• Left Ventricular Dysfunction
• Multi Organ Failure
• Multiple Organ Failure
• Myocardial Infarction
• Right Ventricular Dysfunction
• Tako Tsubo Cardiomyopathy
• Takotsubo Cardiomyopathy
• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Echocardiography
All patients in the study will be examined with echocardiography
• Cardiac magnetic resonance imaging
Sub-group of patients with left ventricular systolic dysfunction will be examined with cMRI
• Coronary CT
Sub-group of patients with left ventricular systolic dysfunction will be examined with CCT

Locations

Country	Name	City	State
Sweden	Sahgrensak University Hospital	Västra Frölunda	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-days mortality	Death	90 days
Secondary	Alive outside ICU	Days alive while not in the ICU	90 days
Secondary	Alive without mechanical ventilation	Days alive and without mechanical ventilation	90 days
Secondary	Alive without CRRT	Days alive without CRRT	90 days