- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03066141
Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease
The Prevalence and Influence of Obstructive Sleep Apnea in Coronary Artery Disease in Modern Age: Findings in A Large Cohort Study
연구 개요
상태
정황
상세 설명
Before initiating the study, all potential subjects were invited to attend an educational program that explained the purpose and methodology of this study. After getting informed consent from patients, demographic data including age, sex, medical history (including comorbidities and risk factors), current medicine, lifestyle habits, height (cm), and weight (kg) were recorded, and body mass index (BMI) was calculated as weight divided by height squared (kilograms per square meter, kg/m2). The included subjects need to perform transthoracic echocardiography or provide an echocardiographic examination within one month. CAD diagnosis was determined based on the results of the coronary angiography, using stenosis 50% cutoffs considered have coronary diseases or not.
Consecutive patients of both sexes with coronary angiography from outpatient or inpatient departments of Fuwai Hospital were recruited into the study. The inclusion criteria were Chinese, aged 35 to 75 years with CAD verified by coronary angiography, and able to give informed written consent. The subjects were excluded if they had New York Heart Association Class III-IV degree with ejection fraction < 45%, severe pulmonary disease, significant psychiatric disease, or history of pharyngeal surgery for OSA or current use of CPAP treatment for OSA. They were also excluded if they declined to participate or were unable to provide informed consent.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Beijing, 중국, 100037
- Center of pulmonary vascular disease, Fuwai hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- aged 35 to 75 years with CAD
- CAD was verified by coronary angiography
Exclusion Criteria:
- Patients had New York Heart Association Class III-IV degree with ejection fraction < 45%
- Severe pulmonary disease
- Significant psychiatric disease
- History of pharyngeal surgery for OSA or current use of CPAP treatment for OSA
- Subjects declined to participate or were unable to provide informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
CAD with OSA
coronary artery disease with Obstructive sleep apnea
|
CAD without OSA
coronary artery disease without Obstructive sleep apnea
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease
기간: 12 months
|
The apnea-hypopnea index (AHI) was calculated as the total number of apneas and hypopneas occurring per hour of sleep.
And the severity of coronary artery disease was determined by Coronary angiography.
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China
기간: 12 months
|
The number of patients with Obstructive Sleep Apnea in Coronary Artery Disease in China
|
12 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Zhihong Liu, M.D, Fuwai Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
관상동맥 질환에 대한 임상 시험
-
Chinese Academy of Medical Sciences, Fuwai HospitalMedtronic; CCRF Consulting Co., Ltd.빼는Transradial-transfemoral Coronary Interventions 비교
-
CCRF Consulting Co., Ltd.Peking University First Hospital; Terumo Medical(shanghai) Co.,Ltd.알려지지 않은심장 또는 뇌혈관 질환 무료 요금 | Transradial-transfemoral Coronary Interventions 비교중국
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Micell TechnologiesCardialysis BV; ClinLogix. LLC알려지지 않은
-
University Medical Center Groningen모병
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); US Department...완전한신장 질환 | 만성 신장 질환 | 급성 신부전 | 관상동맥(Artery); 질병