Coronary Artery DiseaseNCT03874481
The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
An observational study of Coronary Artery Disease and In-stent Restenosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, In-stent Restenosis
- What is being tested?
- Observation
- How many people
- 958 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Coronary arter disease
Who may be able to join
- Clinical diagnosis of Coronary artery disease
- PCI patients in the follow-up
- written informed consent
Who cannot join
- Heart failure; renal failure; secondary hypertension;valvular heart disease ;Cancer;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hongjian Wang
Beijing, Beijing Municipality, 100037
Hongjian Wang, 13910008985 ext. 13910008985, wanghongjianfw@hotmail.com
Yin Dong, 13552582795
About this study
This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.
Read the detailed description
Background: Coronary artery disease (CAD) is the leading cause of mortality in the world. The important treatment of CAD is Percutaneous coronary intervention(PCI). However, in-stent-restenosis(ISR) is the major issue in the PCI. The factors of ISR include gender, age, diabetes, lipid ,obesity and so on.Recently, studies showed that sleep duration and sleep quality have effect on all of factors and have relationship with coronary artery calcification. We like to explore the relationship between sleep quality and CAD/ISR.
Aims:This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.
Methods: We include patients who were diagnosed as CAD by coronary arteriography. Sleep duration and quality were evaluated from sleep questionnaire. During the 6 months and 9-12months, we follow up the patients who got PCI and get information of Major Adverse Cardiovascular Events (MACE) from follow-up questionnaire. On 9-12 months after PCI, coronary arteriography were produced in PCI patients. Biomarkers were tested during the follow-up.
- Conditions
- Coronary Artery Disease, In-stent Restenosis
- Being tested
- Observation
- Keywords
- sleep duration, sleep quality, coronary artery disease, in stent restenosis
- Medical subject headings
- Coronary Artery Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
follow up regularly for MACE
| Study group | Role | What they receive |
|---|---|---|
| PCI | Patients who had stent Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent restenosis
The rate of in stent restenosis
Measured: 9-12 months from PCI
Secondary outcomes (1)
MACE
The rate of cardiovascular(CV) death (death due to a cardiovascular cause), myocardial infarction (MI) or Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization,Hospitalization for CV, Stroke, Death, Heart failure
Measured: 6months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Nov 2018
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 958 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongjian Wang, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874481
- Sponsor's protocol ID
- T2018-ZX026
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
- ClinicalTrials.gov ID
- NCT03874481
- Acronym / sponsor ID
- T2018-ZX026
- Conditions
- Coronary Artery Disease, In-stent Restenosis
- Keywords
- sleep duration, sleep quality, coronary artery disease, in stent restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 958 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.
Detailed description
Background: Coronary artery disease (CAD) is the leading cause of mortality in the world. The important treatment of CAD is Percutaneous coronary intervention(PCI). However, in-stent-restenosis(ISR) is the major issue in the PCI. The factors of ISR include gender, age, diabetes, lipid ,obesity and so on.Recently, studies showed that sleep duration and sleep quality have effect on all of factors and have relationship with coronary artery calcification. We like to explore the relationship between sleep quality and CAD/ISR.
Aims:This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.
Methods: We include patients who were diagnosed as CAD by coronary arteriography. Sleep duration and quality were evaluated from sleep questionnaire. During the 6 months and 9-12months, we follow up the patients who got PCI and get information of Major Adverse Cardiovascular Events (MACE) from follow-up questionnaire. On 9-12 months after PCI, coronary arteriography were produced in PCI patients. Biomarkers were tested during the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI | – | Other: ObservationPatients who had stent |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary arter disease
Key inclusion criteria (3 listed)
- Clinical diagnosis of Coronary artery disease
- PCI patients in the follow-up
- written informed consent
Key exclusion criteria (1 listed)
- Heart failure; renal failure; secondary hypertension;valvular heart disease ;Cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationfollow up regularly for MACE | Other | PCI |
Primary outcome
In-stent restenosis
Time frame: 9-12 months from PCI
The rate of in stent restenosis
1 secondary outcome
MACE
Time frame: 6months, 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and In-stent Restenosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongjian Wang, Dr (13910008985, wanghongjianfw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent restenosis (time frame: 9-12 months from PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.