- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00926874
Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome (AVC/SCA)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Grenoble, 프랑스
- 모병
- University Hospital
-
연락하다:
- Baguet Jean-Philippe, Professor
- 전화번호: 0033476768480
- 이메일: JPBaguet@chu-grenoble.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
1
patients who presented an ischaemic stroke(full stroke or TIA)
|
|
2
patients who present an acute coronary syndrome (ACS).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
biomechanical properties of the carotid arteries
기간: 1-6 months
|
1-6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
aortic stiffness and brachial endothelial function
기간: 1-6 months
|
1-6 months
|
|
blood pressure (BP) levels and the vascular parameters
기간: 1-6 months
|
1-6 months
|
|
respiratory parameters recorded during sleep
기간: 1-6 months
|
1-6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: BAGUET Jean Philippe, Professor, University Hospital, Grenoble
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0401 (Abbott Vascular)
- DGS 2008/0443
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .