Coronary Artery Disease (CAD)MHCRTNCT07660419
Effect of Mobile-Based Home Cardiac Rehabilitation on Coronary Plaque
A study testing mHealth-based Cardiac Rehabilitation Program in people with Coronary Artery Disease (CAD) and Coronary Stenosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This single-center, randomized controlled trial aims to evaluate the efficacy of a mobile internet-based, home-based cardiac rehabilitation program in patients with mild to moderate coronary artery stenosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease (CAD), Coronary Stenosis
- What is being tested?
- mHealth-based Cardiac Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Diagnosis of mild-to-moderate coronary artery stenosis: presence of plaque in any coronary artery causing mild (<50%) or moderate (50%-69%) luminal stenosis.
- 2.Age between 18 and 70 years. 3.Asymptomatic during exercise or recovery phases of cardiopulmonary assessment, including absence of angina, ST-segment depression, or complex arrhythmias at rest or during exercise.
- 4.Normal troponin levels. 5.Provided signed informed consent.
Who cannot join
- 1. Severe coronary artery stenosis. 2.Presence of severe respiratory or cardiovascular diseases (e.g., acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis).
- 3.Angina symptoms or signs during low-intensity exercise (<5 METs) or recovery. 4.Complex arrhythmias at rest or during exercise. 5.Hemodynamic abnormalities during exercise (e.g., failure of systolic blood pressure or heart rate to increase, or a decrease in blood pressure with increased exercise workload).
- 6.Severe psychological disorders. 7.Left ventricular ejection fraction (LVEF) < 40%. 8.Elevated troponin levels. 9.Inability to undergo cardiopulmonary exercise testing due to neuromuscular or musculoskeletal disorders.
- 10.Presence of other severe comorbidities. 11.Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
Xue Feng, +86-10-8839-6216, 29611290@qq.com
Shumin Zhang, +86-10-8839-6216, zhangshumin0302@163.com
About this study
Official title: Effect of Mobile Internet Technology-Based Home Cardiac Rehabilitation on Coronary Artery Plaque in Patients With Mild to Moderate Stenosis
This single-center, randomized controlled trial aims to evaluate the efficacy of a mobile internet-based, home-based cardiac rehabilitation program in patients with mild to moderate coronary artery stenosis. A total of 176 eligible participants will be randomized to receive either a personalized lifestyle intervention via a mobile platform or routine clinical care. The primary endpoint is the change in non-calcified coronary plaque volume, as measured by coronary computed tomography angiography (CTA) at 12 months. Participants will be followed for a total of 36 months to comprehensively assess the long-term impact of this digital lifestyle intervention on plaque progression and cardiovascular outcomes.
- Conditions
- Coronary Artery Disease (CAD), Coronary Stenosis
- Being tested
- mHealth-based Cardiac Rehabilitation Program
- Keywords
- Coronary Artery Disease (CAD), Home-based Cardiac Rehabilitation, Mobile Health (mHealth), Coronary Stenosis, Non-calcified Plaque, Coronary Computed Tomography Angiography (CCTA)
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth-based Cardiac Rehabilitation ProgramBehavioural
The intervention is a comprehensive, personalized cardiac rehabilitation program delivered via a mobile health (mHealth) platform. It consists of three core components: (1) Exercise Prescription: Personalized training plans aiming for 150 minutes of moderate-intensity aerobic exercise per week, combined with strength and flexibility training. (2) Nutritional Guidance: An initial offline nutritional assessment and personalized meal planning, followed by monthly online follow-ups and adjustments. (3) Psychological Support: Motivational interviewing and targeted psychological interventions provided as needed. Additionally, the program utilizes the mHealth platform to provide weekly online community supervision, progress tracking, and continuous health education to enhance patient compliance and engagement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants receiving the home-based cardiac rehabilitation program via a mobile application. Receives: Behavioral: mHealth-based Cardiac Rehabilitation Program |
| Control Group | No intervention | Participants receiving usual care and general health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
chang in non-calcified plaque volume
The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA).
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start31 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660419
- Sponsor's protocol ID
- 2022-GSP-TS-5
- Acronym
- MHCRT
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Internet Technology-Based Home Cardiac Rehabilitation on Coronary Artery Plaque in Patients With Mild to Moderate Stenosis
- ClinicalTrials.gov ID
- NCT07660419
- Acronym / sponsor ID
- MHCRT / 2022-GSP-TS-5
- Conditions
- Coronary Artery Disease (CAD), Coronary Stenosis
- Keywords
- Coronary Artery Disease (CAD), Home-based Cardiac Rehabilitation, Mobile Health (mHealth), Coronary Stenosis, Non-calcified Plaque, Coronary Computed Tomography Angiography (CCTA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 2026 (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 single-center, randomized controlled trial aims to evaluate the efficacy of a mobile internet-based, home-based cardiac rehabilitation program in patients with mild to moderate coronary artery stenosis. A total of 176 eligible participants will be randomized to receive either a personalized lifestyle intervention via a mobile platform or routine clinical care. The primary endpoint is the change in non-calcified coronary plaque volume, as measured by coronary computed tomography angiography (CTA) at 12 months. Participants will be followed for a total of 36 months to comprehensively assess the long-term impact of this digital lifestyle intervention on plaque progression and cardiovascular outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: mHealth-based Cardiac Rehabilitation ProgramParticipants receiving the home-based cardiac rehabilitation program via a mobile application. |
| Control Group | No intervention | –Participants receiving usual care and general health education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Diagnosis of mild-to-moderate coronary artery stenosis: presence of plaque in any coronary artery causing mild (<50%) or moderate (50%-69%) luminal stenosis.
- 2.Age between 18 and 70 years. 3.Asymptomatic during exercise or recovery phases of cardiopulmonary assessment, including absence of angina, ST-segment depression, or complex arrhythmias at rest or during exercise.
- 4.Normal troponin levels. 5.Provided signed informed consent.
Key exclusion criteria (4 listed)
- 1. Severe coronary artery stenosis. 2.Presence of severe respiratory or cardiovascular diseases (e.g., acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis).
- 3.Angina symptoms or signs during low-intensity exercise (<5 METs) or recovery. 4.Complex arrhythmias at rest or during exercise. 5.Hemodynamic abnormalities during exercise (e.g., failure of systolic blood pressure or heart rate to increase, or a decrease in blood pressure with increased exercise workload).
- 6.Severe psychological disorders. 7.Left ventricular ejection fraction (LVEF) < 40%. 8.Elevated troponin levels. 9.Inability to undergo cardiopulmonary exercise testing due to neuromuscular or musculoskeletal disorders.
- 10.Presence of other severe comorbidities. 11.Refusal to sign informed consent.
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 |
|---|---|---|
| mHealth-based Cardiac Rehabilitation ProgramThe intervention is a comprehensive, personalized cardiac rehabilitation program delivered via a mobile health (mHealth) platform. It consists of three core components: (1) Exercise Prescription: Personalized training plans aiming for 150 minutes of moderate-intensity aerobic exercise per week, combined with strength and flexibility training. (2) Nutritional Guidance: An initial offline nutritional assessment and personalized meal planning, followed by monthly online follow-ups and adjustments. (3) Psychological Support: Motivational interviewing and targeted psychological interventions provided as needed. Additionally, the program utilizes the mHealth platform to provide weekly online community supervision, progress tracking, and continuous health education to enhance patient compliance and engagement. | Behavioural | Experimental Group |
Primary outcome
chang in non-calcified plaque volume
Time frame: Baseline and 12 months
The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth-based Cardiac Rehabilitation Program in people with Coronary Artery Disease (CAD) and Coronary Stenosis, 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 4 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Feng (+86-10-8839-6216, 29611290@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chang in non-calcified plaque volume (time frame: Baseline and 12 months). 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 22 Jun 2026.