Stroke Card Long-term Follow-Up

Ischemic Stroke Clinical Trial

Official title:

Long-term Outcome of a Pragmatic Trial of Multifaceted Intervention (STROKE-CARD Care) to Reduce Cardiovascular Risk and Improve Quality-of-life After Ischemic Stroke and Transient Ischemic Attack

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04205006
• Other study ID #: SCFU
• Status: Enrolling by invitation
• Start date: December 16, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2022
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. To further investigate the long-term efficacy of STROKE-CARD care all participants of the original trial will be invited for a Long-term in Person follow-up (3 - 6 years).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion in the previous STROKE-CARD trial (NCT02156778)

• Written informed consent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• TIA

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck, Department of Neurology	Innsbruck	Tyrol
Austria	Hospital St. John's of God	Vienna

Sponsors (4)

Lead Sponsor	Collaborator
Medical University Innsbruck	Barmherzige Brüder Vienna, Tirol Kiniken GmbH, VASCage GmbH

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Boehme C, Toell T, Mayer-Suess L, Domig L, Pechlaner R, Willeit K, Tschiderer L, Seekircher L, Willeit P, Griesmacher A, Knoflach M, Willeit J, Kiechl S. The dimension of preventable stroke in a large representative patient cohort. Neurology. 2019 Dec 3;9 — View Citation

Toell T, Boehme C, Mayer L, Krebs S, Lang C, Willeit K, Prantl B, Knoflach M, Rumpold G, Schoenherr G, Griesmacher A, Willeit P, Ferrari J, Lang W, Kiechl S, Willeit J. Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)	Recurrent stroke	through study completion, an average of 4,5 years
Primary	The composite CVD outcome: nonfatal myocardial infarction	Major recurrent (post-discharge) cardiac event	through study completion, an average of 4,5 years
Primary	The composite CVD outcome: vascular death	death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, cardiovascular procedures, and death due to other CV causes.	through study completion, an average of 4,5 years
Primary	self-reported health-related quality of life	quantified with the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) overall health utility score14 with rescaled European visual analogue scale weights.	through study completion, an average of 4,5 years
Secondary	The composite outcome of stroke/TIA	TIA defined as transient neurological deficit <24h and absence of DWI positive lesions on MRI	through study completion, an average of 4,5 years
Secondary	all-cause mortality	death from all causes	through study completion at long term follow up visit, an average of 4,5 years
Secondary	EQ-ED-3L	individual 3-level components of the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire14 (i.e. mobility, self-care, usual activities, no pain or discomfort, no anxiety or depression) comparing people reporting no problems (level 1) with those reporting problems (level 2 and 3)	through study completion at long term follow up visit, an average of 4,5 years
Secondary	Proportions of participants achieving target levels of risk factors in each trial arm of the previous STROKE-CARD trial.	Blood pressure <140/<90 mmHg or <130/<85 mmHg in patients with diabetes mellitus, severe renal impairment; HbA1c <7.5% at the study visit in patients with diabetes mellitus; having quit smoking by the study visit in patients that had been smokers at baseline in the STROKE-CARD trial; LDL cholesterol < 100 mg/dL or <70 mg/dL in high-risk patients (i.e. stroke or TIA due to large-artery atherosclerosis or small-vessel occlusion, other evidence of atherosclerotic vascular disease, baseline diabetes; Metabolic Syndrome (NCEP-ATPIII): reduction of component number by 1, physical activity >90 minutes; Platelet inhibitor or oral anticoagulation; Oral anticoagulation (INR 2-3, Time in Therapeutic Range (TTR)>70%) in case of atrial fibrillation (AF), Lipid-lowering medication except for non-atherosclerotic strokes (e.g. vessel dissection).	through study completion at long term follow up visit, an average of 4,5 years