Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— AVC/SCA  

Official title:

A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00926874
• Other study ID #: 0401
• Secondary ID: DGS 2008/0443
• Status: Recruiting
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: August 21, 2009
• Start date: November 2005
• Est. completion date: October 2009

Study information

• Verified date: August 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Ischemia
• Ischemic Stroke
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Syndrome

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biomechanical properties of the carotid arteries		1-6 months	No
Secondary	aortic stiffness and brachial endothelial function		1-6 months	No
Secondary	blood pressure (BP) levels and the vascular parameters		1-6 months	No
Secondary	respiratory parameters recorded during sleep		1-6 months	No