Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04352790
• Other study ID #: 402/2009BO2, 522/2012BO2
• Status: Active, not recruiting
• Start date: March 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 878
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Acute intracranial hemorrhage

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

References & Publications (1)

Poli S, Diedler J, Härtig F, Götz N, Bauer A, Sachse T, Müller K, Müller 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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of any stroke	Recurrent ischemic stroke or intracranial hemorrhage during follow-up	= 12 months
Secondary	Rate of mortality	Death from any cause during follow-up	= 12 months
Secondary	Rate of ischemic stroke	Ischemic stroke recurrence during follow-up	= 12 months
Secondary	Rate of transient ischemic attack	Transient ischemic attack recurrence during follow-up	= 12 months
Secondary	Rate of systemic embolism	Systemic embolism during follow-up	= 12 months
Secondary	Rate of myocardial infarction	Myocardial infarction during follow-up	= 12 months
Secondary	Rate of intracranial hemorrhage	Intracranial hemorrhage during follow-up	= 12 months
Secondary	Rate of major Bleedings	Major Bleedings during follow-up	= 12 months
Secondary	Rate of major or clinically relevant non-major bleedings	Major or clinically relevant non-major bleedings during follow-up	= 12 months
Secondary	Rate of serious adverse events	Serious adverse events during follow-up	= 12 months
Secondary	Rate of new-onset atrial fibrillation	Detection of atrial fibrillation during follow-up	= 12 months
Secondary	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