Clinical trial NCT00926874: Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
Official title: A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Acute Coronary Syndrome
Obstructive Sleep Apnea Syndrome
Keywords: ischaemic stroke
acute coronary syndrome
obstructive sleep apnea syndrome
brachial endothelial function
blood pressure
aortic stiffness
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-06-24
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: biomechanical properties of the carotid arteries
timeFrame: 1-6 months
Secondary outcomes:
measure: aortic stiffness and brachial endothelial function
timeFrame: 1-6 months
measure: blood pressure (BP) levels and the vascular parameters
timeFrame: 1-6 months
measure: respiratory parameters recorded during sleep
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: BAGUET Jean Philippe, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.