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
  Purpose

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.


Condition Phase
Ischemic Stroke
Acute Coronary Syndrome
Obstructive Sleep Apnea Syndrome
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • biomechanical properties of the carotid arteries [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum


Estimated Enrollment: 150
Study Start Date: November 2005
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients who presented an ischaemic stroke(full stroke or TIA)
2
patients who present an acute coronary syndrome (ACS).

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926874

Locations
France
University Hospital Recruiting
Grenoble, France
Contact: Baguet Jean-Philippe, Professor    0033476768480    JPBaguet@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: BAGUET Jean Philippe, Professor University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble, Pr Jean-PHilippe BAGUET
ClinicalTrials.gov Identifier: NCT00926874     History of Changes
Other Study ID Numbers: 0401, DGS 2008/0443
Study First Received: March 23, 2009
Last Updated: August 21, 2009
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:
ischaemic stroke
acute coronary syndrome
obstructive sleep apnea syndrome
brachial endothelial function
blood pressure
aortic stiffness

Additional relevant MeSH terms:
Apnea
Ischemia
Sleep Apnea Syndromes
Stroke
Cerebral Infarction
Sleep Apnea, Obstructive
Acute Coronary Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain

ClinicalTrials.gov processed this record on August 28, 2014