a) Determine whether acute cardiac CT has a higher probability of diagnosing LA thrombi compared to TEE or repeated cardiac CT in the subacute phase of ischemic stroke by assessing the rate at which LA thrombi dissolve in the first days after…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Rate at which LA thrombi visualized on acute cardiac CT dissolve in the
first days after ischemic stroke.
2) False-positive rate for detection of left atrial thrombi on acute cardiac CT
compared to TEE.
Secondary outcome
- Secondary outcomes include other pre-defined high-risk and non-high-risk
sources of embolism on cardiac CT and TEE, which will also be systematically
assessed according to predefined criteria.These sources of embolism are:
o Left ventricular thrombus,
o Prosthetic valve abnormalities (pannus or thrombus),
o Signs of endocarditis (e.g., valvular vegetations),
o Atrial myxoma,
o Papillary fibroelastoma,
o Sign of myocardial infarction,
o Signs of rheumatic valvular disease (mitral stenosis),
o Left atrial appendage morphology,
o Left atrial appendage slow-flow,
o Left atrial (appendage) volume,
o Atrial diverticulum,
o Left ventricular apical aneurysm,
o Patent foramen ovale,
o Atrial septal defect,
o Aortic atherosclerotic plaque, including size, ulceration and composition
- We will assess the clinical impact of detecting cardiac thrombi and other
sources of embolism on acute cardiac CT and TEE, including any impact on stroke
etiology according to Trial of Org 10172 in Acute Stroke Treatment (TOAST)
criteria.3 Any complications resulting from cardiac CT (i.e. contrast allergy
and contrast induced nephropathy) and TEE will be recorded.
Background summary
Cardiac CT acquired during the acute stroke imaging protocol (acute cardiac CT)
has recently been shown to have a superior diagnostic yield than transthoracic
echocardiography, which is currently the most commonly used method to screen
for structural sources of cardioembolism in patients with acute ischemic
stroke. The most common finding on acute cardiac CT are cardiac thrombi located
in the left atrium (LA) and specifically the left atrial appendage (LAA). The
higher diagnostic yield of acute cardiac CT compared to TTE is partially
explained because CT allows for better visualization of the LAA, but also
because cardiac thrombi may dissolve in the first days after stroke. Whether
acute cardiac CT is the optimal diagnostic modality for LA thrombi in stroke
patients is unknown, since data comparing it to transoesophageal
echocardiography (TEE), which is the reference standard to detect LA thrombi,
are lacking. The general hypothesis of this study is that acute cardiac CT is
the optimal method to detect LA thrombi in ischemic stroke patients, since TEE
can miss LA thrombi that dissolve in the first days after stroke.
Study objective
a) Determine whether acute cardiac CT has a higher probability of diagnosing
LA thrombi compared to TEE or repeated cardiac CT in the subacute phase of
ischemic stroke by assessing the rate at which LA thrombi dissolve in the first
days after ischemic stroke occurrence.
b) Determine the positive predictive value of acute cardiac CT compared to TEE
for the detection of LA thrombi.
Study design
Prospective, multi-centre, observational cohort. Patients will undergo acute
cardiac CT as part of routine clinical care. Patients will undergo
transoesophageal echocardiography in Amsterdam UMC for research purposes and in
UZ Leuven as part of standard clinical practise. Thereby, patients will undergo
repeated cardiac CT for research purposes in both centers. The repeated cardiac
CT is essential to determine the rate at which cardiac thrombi dissolve and ,
in case a thrombus is not visualized on TEE, to make the distinction between a
false-positive findings on the initial cardiac CT and a thrombus which has
dissolved.
Study burden and risks
Clinical and imaging patient data which are obtained as part of standard care
will be prospectively collected after written informed consent. Patient with a
LA thrombus on acute cardiac CT will undergo TEE in Amsterdam UMC for research
purposes after obtaining written informed consent and in UZ Leuven as part of
standard clinical practise. TEE is semi-invasive and associated with a small
risk of major complications (<0.2%). Patients will also be exposed to
additional radiation (1.4 mSv) due to sequential cardiac CT after TEE. The
Radiation Dose Committee deemed this to be a intermediate risk. In a small
minority of patients (<10%), another cardiac CT will be acquired 2 minutes
after this sequential cardiac CT to ensure a clear, final assessment of the
presence of an atrial appendage thrombus. This will result in a total
additional radiation of around 3 mSv for the two additional cardiac CT*s. The
Radiation Dose Committee deemed this to be an intermediate risk. As part of
standard care, patients will be contacted for follow-up evaluation by a trained
stroke nurse at 90 days. This information will be used in the current study.
As a result of ischemic stroke, some patients become incapacitated to an extent
they are unable to give informed consent. In these cases, the legal
representative will be asked for informed consent. Decreased leveI of
consciousness or aphasia are typical clinical characteristics of cardioembolic
stroke. Therefore, it is pivotal to also include incapacitated acute ischemic
stroke patients. Excluding these patients from the study would render the study
non-representative of the study*s target population (acute ischemic stroke
patients with cardioembolic stroke due to LA thrombus).
Eerste van der Helststraat 80-2
Amsterdam 1072NZ
NL
Eerste van der Helststraat 80-2
Amsterdam 1072NZ
NL
Listed location countries
Age
Inclusion criteria
Population (base)
Patients 18 years or older with acute ischemic stroke and a left atrial
thrombus detected on cardiac CT acquired during the initial stroke imaging
protocol at Amsterdam UMC, location AMC.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Age 18 years or older
• Clinical diagnosis of acute ischemic stroke
• Written informed consent from patient or representative
• Radiological diagnosis of cardiac thrombus in the LA, including the LAA, on
cardiac CT acquired during the initial stroke imaging protocol.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Patients with a diagnosis other than acute ischemic stroke, such as:
transient ischemic attack, intracerebral haemorrhage, subarachnoid haemorrhage,
epilepsy, tumor.
• Absolute contraindication for TEE:
o Perforated viscus
o Esophageal stricture
o Esophageal tumor
o Esophageal perforation, laceration
o Esophageal diverticulum
o Active upper GI bleed
• Absolute contraindication for repeat cardiac CT
o Documented previous severe reaction to iodinated contrast media, including
anaphylaxis, angioedema and bronchospasm.
o Severely impaired kidney function defined as estimated glomerular filtration
rate of 30 mL/min/1.73 m2.
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 |
|---|---|
| CCMO | NL84141.018.23 |