Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease

Multifactorial Risk Stratification in Patients With Ischemic Stroke or Transient Ischemic Attack and Structural, Inflammatory, or Arrhythmogenic Cardiac Disease

Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.

Study Overview

• Status: Unknown
• Conditions: Stroke; Cardiac Disease

Detailed Description

The prospective registry shall provide new insights into the multiple associations, and respective therapeutic implications of cardio-vascular risk factors and stroke. For that reason consecutive patients with ischemic stroke/transient ischemic attack (brain, spinal cord, or retinal) and structural (e.g. patent foramen ovale), septic or aseptic endocarditis or myocarditis, or supra-ventricular or ventricular arrhythmia, who are admitted to our University Hospital, are enrolled. Multifactorial assessment of risk factors is based on medical history, laboratory biomarkers, electrocardiogram incl. cardiac autonomic function analysis, and (long-term) cardiac rhythm monitoring, as well as transthoracic and transesophageal echocardiography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of routine diagnostic and therapeutic interventions for secondary stroke prevention (e.g. implantable loop recorders or interventional closure of patent foramen ovale).

• Study Type: Observational
• Enrollment (Actual): 878

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive ischemic stroke/transient ischemic attack patients (brain, spinal crd, or retinal) with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.

Description

Inclusion Criteria:

• Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)

Exclusion Criteria:

• Acute intracranial hemorrhage

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of any stroke	Recurrent ischemic stroke or intracranial hemorrhage during follow-up	≥ 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mortality	Death from any cause during follow-up	≥ 12 months
Rate of ischemic stroke	Ischemic stroke recurrence during follow-up	≥ 12 months
Rate of transient ischemic attack	Transient ischemic attack recurrence during follow-up	≥ 12 months
Rate of systemic embolism	Systemic embolism during follow-up	≥ 12 months
Rate of myocardial infarction	Myocardial infarction during follow-up	≥ 12 months
Rate of intracranial hemorrhage	Intracranial hemorrhage during follow-up	≥ 12 months
Rate of major Bleedings	Major Bleedings during follow-up	≥ 12 months
Rate of major or clinically relevant non-major bleedings	Major or clinically relevant non-major bleedings during follow-up	≥ 12 months
Rate of serious adverse events	Serious adverse events during follow-up	≥ 12 months
Rate of new-onset atrial fibrillation	Detection of atrial fibrillation during follow-up	≥ 12 months
modified Rankin Score; range from 0 to 6, with '0' indicating the best outcome (i.e. no deficit), and '6' the worst outcome (i.e. death)	modified Rankin Scale score at follow-up	≥ 12 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Publications and helpful links

General Publications

• Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.
• Poli S, Siebert E, Mbroh J, Poli K, Krumbholz M, Mengel A, Greulich S, Hartig F, Muller KAL, Bocksch W, Gawaz M, Ziemann U, Zuern CS. Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series. Neurol Res Pract. 2021 Apr 1;3(1):16. doi: 10.1186/s42466-021-00114-3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2012
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: atrial fibrillation; transient ischemic attack; autonomic dysfunction; ESUS; patent foramen ovale; heart rhythm monitoring; cryptogenic stroke; loop recorder; retinal ischemia; embolic stroke of undetermined source
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Diseases; Stroke
• Other Study ID Numbers: 402/2009BO2, 522/2012BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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