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Trial record 27 of 244556 for:    Diseases

Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT03066141
Recruitment Status : Enrolling by invitation
First Posted : February 28, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chinese Pulmonary Vascular Disease Research Group

Brief Summary:
It is widely accepted that coronary artery disease (CAD) is related to a high mortality. It is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7 million cardiovascular deaths over 2010 to 2030 in China.1 Male sex, diabetes mellitus, hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as risk factors for CAD. In recent decades, tremendous progress toward the prevention and treatment of traditional cardiovascular risk factors have helped decrease the morbidity and mortality from CAD, but the condition remains a major public health challenge worldwide. Looking into the other potential risk factors (OSA) for CAD, it may help to develop additional preventative strategies and further reduce the incidence and mortality of CAD.

Condition or disease
Coronary Artery Disease

Detailed Description:

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 or without 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Prevalence and Influence of Obstructive Sleep Apnea in Coronary Artery Disease in Modern Age: Findings in A Large Cohort Study
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : December 14, 2020
Estimated Study Completion Date : December 14, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
CAD with OSA
coronary artery disease with Obstructive sleep apnea
CAD without OSA
coronary artery disease without Obstructive sleep apnea



Primary Outcome Measures :
  1. Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China [ Time Frame: 12 months ]
    The number of patients with Obstructive Sleep Apnea in Coronary Artery Disease in China



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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 or without 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.
Criteria

Inclusion Criteria:

  • aged 35 to 75 years with or without 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066141


Locations
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China
center of pulmonary vascular disease, Fuwai hospital
Beijing, China, 100037
Sponsors and Collaborators
Chinese Pulmonary Vascular Disease Research Group
Investigators
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Study Chair: Zhihong Liu, M.D Fuwai Hospital

Additional Information:

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Responsible Party: Chinese Pulmonary Vascular Disease Research Group
ClinicalTrials.gov Identifier: NCT03066141     History of Changes
Other Study ID Numbers: ChinesePVDRG
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Myocardial Ischemia
Sleep Apnea, Obstructive
Arteriosclerosis
Sleep Apnea Syndromes
Apnea
Dyssomnias