Cardiac CT Angiography in Patients With Acute Ischemic Stroke

NCT06176872 | Not Yet Recruiting

• 1 other identifier: 2022-100951-BO-ff
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke; Coronary Artery Disease

Keywords

Computed Tomography Angiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The rate of adverse cardiovascular events (MACE).

  90 and 365 days

Study Arms (2)

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

Retrospective matched cohort

A retrospective matched cohort of patients with acute ischemic stroke who did not receive cardiac computed tomography angiography.

Interventions

Cardiac Computed Tomography Angiography DIAGNOSTIC_TEST

Non-invasive imaging of the heart, the greater vessels and the coronary arteries using computed tomography.

Cardiac Computed Tomography Angiography

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Siemens Healthcare Diagnostics Inc: collaborator

MeSH Terms

Conditions

Ischemic Stroke; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Gabriel Broocks, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Mathias Meyer, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Jennifer Erley, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Erley, MD

CONTACT

+4915157487213; j.erley@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 20, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share