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Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome (AVC/SCA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00926874
First received: March 23, 2009
Last updated: August 21, 2009
Last verified: August 2009

March 23, 2009
August 21, 2009
November 2005
October 2009   (final data collection date for primary outcome measure)
biomechanical properties of the carotid arteries [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
biomechanical properties of the carotid arteries [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926874 on ClinicalTrials.gov Archive Site
  • aortic stiffness and brachial endothelial function [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • blood pressure (BP) levels and the vascular parameters [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • respiratory parameters recorded during sleep [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • aortic stiffness and brachial endothelial function [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • blood pressure (BP) levels and the vascular parameters [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • respiratory parameters recorded during sleep [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome

A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion.

The proposed study aims to investigate and analyse the differences in functional and structural arterial properties between the patients who presented an ischaemic stroke and those who presented ACS. The hypothesis is that the patients in both groups will present differences partly in terms of their "traditional" cardiovascular risk factors, but also in terms of their arterial properties. All of the confounding factors studied (cardiovascular risk factors, treatments) will be taken into account in order to explain the differences in the arterial properties found between the two groups. Furthermore, the prevalence of signs and symptoms in the two populations will be studied.

A comparative study of structural and functional arterial properties after an ischaemic stroke or an acute coronary syndrome

Objectives:

Primary:

  • To determine whether there is a difference in the biomechanical properties of the carotid arteries, assessed by studying their stiffness, after an acute vascular event, depending on whether the event is an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).

Secondary:

  • To determine whether there is a difference in aortic stiffness and brachial endothelial function after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
  • To compare the blood pressure (BP) levels and the vascular parameters of the two patient groups (the ischaemic stroke group and the ACS group).
  • To determine whether there is a difference between the respiratory parameters recorded during sleep after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood, serum

Non-Probability Sample

Patients who presented an acute vascular event :an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).

  • Ischemic Stroke
  • Acute Coronary Syndrome
  • Obstructive Sleep Apnea Syndrome
Not Provided
  • 1
    patients who presented an ischaemic stroke(full stroke or TIA)
  • 2
    patients who present an acute coronary syndrome (ACS).
Barone-Rochette G, Vanzetto G, Detante O, Quesada JL, Hommel M, Mallion JM, Baguet JP. Imaging of functional and structural alterations of large arteries after acute ischaemic atherothrombotic stroke or acute coronary syndromes. Arch Cardiovasc Dis. 2014 Aug-Sep;107(8-9):443-51. doi: 10.1016/j.acvd.2014.05.007. Epub 2014 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients
  • Between 40 and 70 years of age
  • Who have given their written consent
  • Who have presented the following between 5 and 30 days prior to inclusion:
  • either an ischaemic stroke (full stroke or TIA) that has been stabilised from a neurological point of view, with no haemorrhage but with direct signs of ischaemia on the cerebral imaging (computed tomography or MRI), diagnosed during patient questioning and/or the clinical examination;
  • or an ACS that has been stabilised from a cardiological point of view, with troponin elevation in at least 2 samples and/or ECG changes that indicate acute myocardial ischaemia, diagnosed during patient questioning.
  • Who are affiliated to the French social security system

Exclusion Criteria:

  • For patients included in the ACS group

    • Stroke less than 6 months ago
    • Coronary bypass between the start of their hospitalisation for ACS and inclusion
  • For patients included in the stroke group

    • Emboligenic heart disease
    • ACS less than 6 months ago
  • For all patients

    • Atrial fibrillation or flutter, or frequent extrasystole (more than 10/minute) upon inclusion
    • History of surgery or carotid stenting
    • Very reduced mobility meaning that they cannot remain standing without assistance or without using a walking stick
Both
40 Years to 70 Years
No
France
 
NCT00926874
0401, DGS 2008/0443
No
University Hospital, Grenoble, Pr Jean-PHilippe BAGUET
University Hospital, Grenoble
Not Provided
Principal Investigator: BAGUET Jean Philippe, Professor University Hospital, Grenoble
University Hospital, Grenoble
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP