NCT02734082

Brief Summary

Many studies have shown that acute cerebral dysfunction can impair cardiac function and autonomic control of blood pressure, heart rate and vascular tone, however, the size of the stroke is rarely reported. Involvement of the insular cortex seems to predispose to cardiac damage and autonomic dysfunction. However, it is not clear whether cardiac dysfunction is merely a marker of large strokes or location of the stroke is critical.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

November 24, 2014

Last Update Submit

April 11, 2016

Conditions

Myocardial InfarctionStroke

Keywords

strokeischemiaBerne

Outcome Measures

Primary Outcomes (2)

  • Association of ischemic lesion size and impaired heart regulation at baseline

    Association is to be determined via multivariate logistic regression. Baseline parameter at inclusion; functional outcome/mortality after 3 months.

    At baseline

  • Association of ischemic lesion size and impaired heart regulation after 3 months

    Association is to be determined via multivariate logistic regression. Baseline parameter at inclusion; functional outcome/mortality after 3 months.

    After 3 months

Study Arms (4)

Elevated Troponin and pathological EC

Patients with acute ischemic stroke with elevated Troponin

No elevated Troponin or pathological EC

Patients with acute ischemic stroke without elevated Troponin

Elevated Troponin, pathological ECG & coronary angiography

Patients with acute ischemic stroke with elevated Troponin T and pathological ECG and coronary angiography

No elevated Troponin, pathological ECG & coronary angiography

Patients with acute ischemic stroke without elevated Troponin T and pathological ECG and coronary angiography

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with acute ischemic stroke hospitalized at Inselpital Berne between 2004-2014.

You may qualify if:

  • Age ≥16 years
  • Hospitalized between 2004-2014
  • Acute MRI imaging performed
  • ECG on admission
  • Cardiac lab parameters on admission (TnT, CK, CK-MB)

You may not qualify if:

  • Age \<16 years
  • No acute MRI image
  • No lab parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Neurology, Bern University Hospital, Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (5)

  • Edelman RR, Mattle HP, Atkinson DJ, Hill T, Finn JP, Mayman C, Ronthal M, Hoogewoud HM, Kleefield J. Cerebral blood flow: assessment with dynamic contrast-enhanced T2*-weighted MR imaging at 1.5 T. Radiology. 1990 Jul;176(1):211-20. doi: 10.1148/radiology.176.1.2353094.

    PMID: 2353094BACKGROUND

  • Mattle HP, Wentz KU, Edelman RR, Wallner B, Finn JP, Barnes P, Atkinson DJ, Kleefield J, Hoogewoud HM. Cerebral venography with MR. Radiology. 1991 Feb;178(2):453-8. doi: 10.1148/radiology.178.2.1987608.

    PMID: 1987608BACKGROUND

  • Galimanis A, Jung S, Mono ML, Fischer U, Findling O, Weck A, Meier N, De Marchis GM, Brekenfeld C, El-Koussy M, Mattle HP, Arnold M, Schroth G, Gralla J. Endovascular therapy of 623 patients with anterior circulation stroke. Stroke. 2012 Apr;43(4):1052-7. doi: 10.1161/STROKEAHA.111.639112. Epub 2012 Feb 23.

    PMID: 22363057BACKGROUND

  • Heldner MR, Zubler C, Mattle HP, Schroth G, Weck A, Mono ML, Gralla J, Jung S, El-Koussy M, Ludi R, Yan X, Arnold M, Ozdoba C, Mordasini P, Fischer U. National Institutes of Health stroke scale score and vessel occlusion in 2152 patients with acute ischemic stroke. Stroke. 2013 Apr;44(4):1153-7. doi: 10.1161/STROKEAHA.111.000604. Epub 2013 Mar 7.

    PMID: 23471266BACKGROUND

  • Walpoth BH, Walpoth-Aslan BN, Mattle HP, Radanov BP, Schroth G, Schaeffler L, Fischer AP, von Segesser L, Althaus U. Outcome of survivors of accidental deep hypothermia and circulatory arrest treated with extracorporeal blood warming. N Engl J Med. 1997 Nov 20;337(21):1500-5. doi: 10.1056/NEJM199711203372103.

    PMID: 9366581BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionStrokeIschemia

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Heinrich P Mattle, Prof. MD

    Dep. of Neurology, Bern University Hospital, Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

April 12, 2016

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations

CH(1)