Cardiac CT Angiography in Patients With Acute Ischemic Stroke (ACUTE)

Assessment of Cardiac CT Angiography in Patients Undergoing Thrombectomy for Ischemic Stroke

Mortality rates after acute ischemic stroke remain high despite continuously improving treatment. In this context, it is important to note that a relevant portion of acute ischemic stroke patients die from adverse cardiovascular events, such as myocardial infarction, rather than from complications associated with the stroke itself. A possible reason might be that this patient group often suffers from at least moderate asymptomatic coronary artery disease. This study seeks to integrate cardiac computed tomography angiography into the standard-of-care diagnostic protocol of acute ischemic stroke. The aim of this prospective mono-centric trial is to enable accurate diagnosis of therapy-relevant coronary artery disease, other concomitant cardiac findings and cardiac causes of acute ischemic stroke, without delaying stroke therapy. In the long-run, the goal is to investigate whether cardiac computed tomography angiography and the resulting therapeutic measures (interventions or medications added) can improve functional outcome and rate of adverse cardiac complications in patients with acute ischemic stroke compared to a retrospective matched-cohort of patients without cardiac CT imaging.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Acute Ischemic Stroke
• Intervention / Treatment: Diagnostic test: Cardiac Computed Tomography Angiography

• Study Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

• Study Contact: Name: Jennifer Erley, MD; Phone Number: +4915157487213; Email: j.erley@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf (primary care clinic) with a suspected AIS.

Description

Inclusion Criteria:

• Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf with a suspected acute ischemic stroke and a relevant neurological deficit (NIHSS score > 4).

Exclusion Criteria:

• A causal differential diagnosis for the acute stroke syndrome with absent intracranial vessel occlusion.
• No correlation for the patients' symptoms in the cranial CTA (no vessel obstruction).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Computed Tomography Angiography; Patients with acute ischemic stroke who receive cardiac computed tomography angiography as part of the routine diagnostic work-up of acute ischemic stroke.	Diagnostic test: Cardiac Computed Tomography Angiography; Non-invasive imaging of the heart, the greater vessels and the coronary arteries using computed tomography.
Retrospective matched cohort; A retrospective matched cohort of patients with acute ischemic stroke who did not receive cardiac computed tomography angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of therapy-relevant CAD and concomitant cardiac findings resulting in new therapeutic measurements.	Number of (newly) prescribed medications (e.g., anticoagulants), cardiac diagnostics/interventions/planned interventions, clinical status (NIHSS, mRs).	1 day at hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of adverse cardiovascular events (MACE).	rate of major adverse cardiovascular events (MACE).	90 and 365 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Siemens Healthcare Diagnostics Inc
• Investigators: Principal Investigator: Gabriel Broocks, MD, Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Mathias Meyer, MD, Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Jennifer Erley, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Computed Tomography Angiography
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Ischemia; Coronary Disease; Infarction; Brain Infarction; Stroke; Coronary Artery Disease; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2022-100951-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to data protection agreements, it is not possible to share the IPD. Nevertheless,parts of the datasets can be made available from the PIs upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No