Stable Chronic AnginaNCT04795492
Effect of Remote Intervention in Patients With SCAD
A study testing remote intervention and Routine outpatient follow-up in people with Stable Chronic Angina and Ischemic Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stable Chronic Angina, Ischemic Heart Disease, Coronary Artery Disease
- What is being tested?
- remote intervention and Routine outpatient follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to Apr 2023
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-99 years
- Diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
- Have sufficient Chinese language proficiency to reading, speaking and listening
- Live with at least one caregiver or guardian in the household
- Presence of stable hemodynamics without using vasopressor
- Able to individually consent
- Not participating in any other clinical trial
Who cannot join
- Unable to provide informed consent
- Unable to be involved in clinical follow-up and treatment
- Suffered comorbidity with a life expectancy of less than 1 year
- Have contra-indication to cardiac rehabilitation
- Acute coronary syndrome
- History of noncompliance with medical therapy
Show all 10Show fewer
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
- Planned major surgery necessitating interruption of antiplatelet therapy
- Inability to comply with the protocol
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100000
About this study
The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.
Read the detailed description
Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease.
Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up.
Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up.
Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker.
Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
- Conditions
- Stable Chronic Angina, Ischemic Heart Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia
- Being tested
- remote intervention, Routine outpatient follow-up
- Medical subject headings
- Angina, Stable, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote interventionBehavioural
Medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. Risk factor modification included lipid control, smoking and drinking cessation, BP monitoring, dietary change keeping a healthy weight and in our trial. There were also a lot of educational materials about coronary heart disease knowledge that were reviewed by cardiologists, and participants were free to provide them whenever and wherever they want.
Routine outpatient follow-upBehavioural
Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Remote intervention Receives: Behavioral: remote intervention |
| Control group | Active comparator | Routine outpatient follow-up Receives: Behavioral: Routine outpatient follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Compliance and administration of cardiovascular protective drugs
Measured: 1 year
Secondary outcomes (12)
Blood Pressure
BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements
Measured: 1 year
Body Mass Index
standard protocol
Measured: 1 year
LDL Cholesterol
standard protocol
Measured: 1 year
HbA1c
standard protocol
Measured: 1 year
Smoking
self-reported
Measured: 1 year
Drinking
self-reported
Measured: 1 year
Aspirin
self-reported
Measured: 1 year
P2Y12 receptor antagonist
self-reported
Measured: 1 year
Statin
self-reported
Measured: 1 year
ACEI/ARB
self-reported
Measured: 1 year
Beta-blocker
self-reported
Measured: 1 year
MACCE
acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Apr 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Unable to recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stable Chronic AnginaStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Song, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Weihua Song, MD, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795492
- Sponsor's protocol ID
- ERIP
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
PubMed 30998400Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
PubMed 32745732Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.
PubMed 32858284
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Intervention in Patients With SCAD
- ClinicalTrials.gov ID
- NCT04795492
- Acronym / sponsor ID
- ERIP
- Conditions
- Stable Chronic Angina, Ischemic Heart Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit enough patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Mar 2021 (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.
The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.
Detailed description
Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease.
Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up.
Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up.
Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker.
Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: remote interventionRemote intervention |
| Control group | Active comparator | Behavioral: Routine outpatient follow-upRoutine outpatient follow-up |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18-99 years
- Diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
- Have sufficient Chinese language proficiency to reading, speaking and listening
- Live with at least one caregiver or guardian in the household
- Presence of stable hemodynamics without using vasopressor
Key exclusion criteria (10 listed)
- Unable to provide informed consent
- Unable to be involved in clinical follow-up and treatment
- Suffered comorbidity with a life expectancy of less than 1 year
- Have contra-indication to cardiac rehabilitation
- Acute coronary syndrome
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 |
|---|---|---|
| remote interventionMedication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. Risk factor modification included lipid control, smoking and drinking cessation, BP monitoring, dietary change keeping a healthy weight and in our trial. There were also a lot of educational materials about coronary heart disease knowledge that were reviewed by cardiologists, and participants were free to provide them whenever and wherever they want. | Behavioural | Intervention group |
| Routine outpatient follow-upParticipants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. | Behavioural | Control group |
Primary outcome
Medication adherence
Time frame: 1 year
Compliance and administration of cardiovascular protective drugs
12 secondary outcomes
Blood Pressure
Time frame: 1 year
Body Mass Index
Time frame: 1 year
LDL Cholesterol
Time frame: 1 year
HbA1c
Time frame: 1 year
Smoking
Time frame: 1 year
Drinking
Time frame: 1 year
Aspirin
Time frame: 1 year
P2Y12 receptor antagonist
Time frame: 1 year
Statin
Time frame: 1 year
ACEI/ARB
Time frame: 1 year
Beta-blocker
Time frame: 1 year
MACCE
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 30998400Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
- Background: PubMed 32745732Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
- Background: PubMed 32858284Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.
- 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.
Weihua Song, MD principal investigator
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote intervention and Routine outpatient follow-up in people with Stable Chronic Angina and Ischemic Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 8 Feb 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795492, which also lists 3 linked publications.
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 8 Feb 2024.