Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585228
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Detecting Cardiac Thrombi in Acute Ischemic Stroke on Cardiac CT Versus Transoesophageal Echocardiography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Detecting Cardiac Thrombi in Acute Ischemic Stroke on Cardiac CT Versus Transoesophageal Echocardiography MtH-DETECT
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MtH-DETECT
Brief Summary:
Rationale
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
Objectives
1 Determine whether acute cardiac CT has a higher diagnostic probability of detecting 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
2 Determine the positive predictive value of acute cardiac CT compared to TEE for the detection of LA thrombi Study design Prospective single-centre observational cohort Study population 39 patients of 18 years or older with acute ischemic stroke and a LA thrombus detected on cardiac CT acquired during the acute stroke imaging
Main study parametersendpoints
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 Nature and extent of the burden and risks associated with participation benefit and group relatedness 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 for research purposes after obtaining written informed consent TEE is semi-invasive and associated with a small risk of major complications 02 Patients will also be exposed to additional radiation 14 mSV due to sequential cardiac CT after TEE The Radiation Dose Committee deemed this to be an 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 3 mSV for the two additional cardiac CTs 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 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 studys target population acute ischemic stroke patients with cardioembolic stroke due to LA thrombus
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
Objectives
1 Determine whether acute cardiac CT has a higher diagnostic probability of detecting 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
2 Determine the positive predictive value of acute cardiac CT compared to TEE for the detection of LA thrombi Study design Prospective single-centre observational cohort Study population 39 patients of 18 years or older with acute ischemic stroke and a LA thrombus detected on cardiac CT acquired during the acute stroke imaging
Main study parametersendpoints
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 Nature and extent of the burden and risks associated with participation benefit and group relatedness 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 for research purposes after obtaining written informed consent TEE is semi-invasive and associated with a small risk of major complications 02 Patients will also be exposed to additional radiation 14 mSV due to sequential cardiac CT after TEE The Radiation Dose Committee deemed this to be an 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 3 mSV for the two additional cardiac CTs 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 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 studys target population acute ischemic stroke patients with cardioembolic stroke due to LA thrombus
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None