Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease

• Conditions: Cardiac Disease; Stroke

• Registration Number: NCT04352790
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

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 Timeline

• Study Start: 2012-03-01
• Primary Completion: 2019-11-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-20
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 878

Inclusion Criteria

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

Exclusion Criteria

• Acute intracranial hemorrhage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of any stroke	≥ 12 months	Recurrent ischemic stroke or intracranial hemorrhage during follow-up

Secondary Outcome Measures

Name	Time	Method
Rate of mortality	≥ 12 months	Death from any cause during follow-up
Rate of systemic embolism	≥ 12 months	Systemic embolism during follow-up
Rate of myocardial infarction	≥ 12 months	Myocardial infarction during follow-up
Rate of intracranial hemorrhage	≥ 12 months	Intracranial hemorrhage during follow-up
Rate of serious adverse events	≥ 12 months	Serious adverse events during follow-up
Rate of new-onset atrial fibrillation	≥ 12 months	Detection of atrial fibrillation during follow-up
Rate of ischemic stroke	≥ 12 months	Ischemic stroke recurrence during follow-up
Rate of transient ischemic attack	≥ 12 months	Transient ischemic attack recurrence during follow-up
Rate of major Bleedings	≥ 12 months	Major Bleedings during follow-up
Rate of major or clinically relevant non-major bleedings	≥ 12 months	Major or clinically relevant non-major bleedings during follow-up
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)	≥ 12 months	modified Rankin Scale score at follow-up