INSPiRE-TMS
Intensified Secondary Prevention intending a Reduction of vascular re-events after TIA or Minor Stroke
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Project description
INSPiRE-TMS compared the effect of a structured, two-year follow-up program with regard to the frequency of secondary strokes, acute coronary syndrome and vascular deaths compared to outpatient follow-up according to standard care in patients with minor ischaemic strokes or TIA (Transitory Ischaemic Attack).
In the course of the structured follow-up program, the patients received a comprehensive counseling interview at weeks 3, 6 and 12 as well as at 6, 9, 12, 18 and 24 months after inclusion in the study. This included general information on stroke prevention and risk factors – with a special focus on lifestyle intervention and adherence to therapy. During these counselling appointments, physical fitness and the current individual risk profile (blood pressure, LDL cholesterol, smoking, etc.) were also assessed. The study was conducted at six German and one Danish hospitals with a Stroke Unit. A total of 2,098 patients were included, half underwent the structured follow-up programme, the other half the normal outpatient follow-up.
Background
Several evidence-based strategies are available for secondary prevention after stroke, such as blood pressure lowering, cholesterol lowering, platelet function inhibitors for arterial strokes and oral anticoagulation (blood thinning) for patients with atrial fibrillation. However, these measures are often not (sufficiently) implemented in routine care, partly because the patients concerned underestimate the need for consistent secondary prevention or are overwhelmed by it, and partly because outpatient care is not extensive enough.
Results
The study confirmed that with the support program an improvement in the risk factor setting could be observed, but this did not lead to a significant reduction in recurrent severe vascular events such as stroke or myocardial infarction. After a mean follow-up of 3.6 years, 175 of the conventionally followed-up patients and 163 of the patients in the follow-up program experienced a major vascular event according to the primary endpoint. With a reduction in relative risk of 8%, the difference between the groups was not significant. However, vascular risk factors were better controlled in the patients in the support program. For example, after 12 months, significantly more patients in the intervention group had blood pressure values in the target range, lower LDL values and higher physical activity and non-smoking rates.
A series of complementary analyses are currently underway, e.g. how the change in body weight affects the risk of recurrence and whether a better secondary prevention setting can at least reduce so-called silent cerebral infarctions.
Team
Principal Investigator
- Prof. Heinrich A. Audebert, MD
Steering Committee
- Inga Laumeier, MD
- Michael Ahmadi, MD
- Thomas Ihl, MD
- Maureen Steinicke, MD
- Gabriele Nieweler
Prevention and Study Nurses
- Sabine Wunderlich
- Gabriela May
- Katrin Hayens
Additional Researchers
- Ramanan Ganeshan, MD
- Juliane Herm, MD
- Philipp Klyscz
- Prof. Jan Scheitz, MD
Clinical Endpoint Committee
- Prof. Peter Marx, MD
- Prof. Otto Busse, MD
- Prof. Friedrich Köhler, MD
Data Monitoring Committee
- Prof. Pierre Amarenco, MD, Paris, France
- Prof. Jakoba Greving, PhD, Utrecht, Netherlands
Cooperation Partners
- University Hospital Aarhus, Denmark: Paul von Weitzel-Mudersbach, PhD
- Klinikum Ludwigshafen: Prof. Dr Armin Grau, MD, Susanne Streib
- Rechts der Isar Hospital of the Technical University of Munich: Prof. Bernhard Hemmer, MD, Christian Seifert, MD
- Martin Wimmer, MD, Praxis am Prinzregentenplatz, Munich
- Prof. Wolfram Döhner, MD, Center for Stroke Research Berlin
- Prof. Jochen Fiebach, MD, Center for Stroke Research Berlin
- Prof. Michael Michelson, MD, Department of Ophthalmology, University Hospital Erlangen
- Prof. Holger Gerhard, Max-Delbrück-Centrum, Berlin-Buch