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Atrial FibrillationMIRACLE-AFNCT04622514

New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China

A study testing Village doctor-led telemedicine integrated care in people with Atrial Fibrillation and Older, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This cluster randomization study aims to compare the village-doctor led telemedicine integrated care versus usual care to improve compliance with the Atrial Fibrillation Better Care (ABC) pathway components and outcomes for older patients with atrial fibrillation in rural China. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Atrial Fibrillation, Older, Stroke
What is being tested?
Village doctor-led telemedicine integrated care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,039 participants
Where
1 siteChina
Study dates
1 Dec 2020to 30 May 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 1. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1) they are aged 65 years or above; 2) they are diagnosed atrial fibrillation by an ECG, AF specialist, or hospital discharge letter; 3) they agree to receive the medical care provided by village clinics; 4) they provide written informed consent.
  • -

Who cannot join

  • Moderate to severe rheumatic mitral stenosis or heart valve replacement history.
  • Presence of ICD or CRT device.
  • Cardiac ablation or surgery <3 months prior to inclusion or being planned.
  • Pulmonary vein isolation or left atrial appendage occlusion history or plan to perform any of the above operations.
  • The life expectancy is less than 1 year.
  • Participation in other clinical trials.
  • -

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 201129

Other trials in China

About this study

Official title: A New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China: a Cluster Randomization Trial (the MIRACLE-AF Trial)

This cluster randomization study aims to compare the village-doctor led telemedicine integrated care versus usual care to improve compliance with the Atrial Fibrillation Better Care (ABC) pathway components and outcomes for older patients with atrial fibrillation in rural China.

Read the detailed description

BACKGROUND Atrial fibrillation（AF) prevalence increases sharply with age, and the risk of stroke, dementia, heart failure and death increases significantly. Integrated care for atrial fibrillation patients using simple ABC pathway ('A' Avoid stroke; 'B' Better symptom management; 'C' Cardiovascular and Comorbidity optimization) is associated with a lower risk of adverse outcomes included all-cause death, composite outcome of stroke/major bleeding/cardiovascular death, and first hospitalization. In China, the prevalence of AF is high, but older people living in rural areas are more vulnerable due to low awareness and treatment gaps caused by various factors. China's rural healthcare system, which is primarily reliant on village doctors, falls short of providing optimal management for AF. To support village doctors in providing integrated care for AF, we have developed a digital health support platform. However, the role of this novel telemedicine-based integrated care for AF patients in rural China remains unclear.

AIM OF THIS STUDY This cluster randomization study aims to compare the village-doctor led telemedicine integrated care versus usual care to improve outcome of older patients with atrial fibrillation in rural China.

DESIGN The MIRACLE-AF China trial is a perspective, cluster randomization clinical trial performed in rural China. We aim to include a minimum of 1000 patients with AF aged 65 years or above from around more than 30 village clinics. Follow-up duration of this study is up to 3 years and all patients are followed up every 3 months by rural doctors. Village clinics will be randomized to either the intervention group (the village-doctor led telemedicine integrated care) or the control group (enhanced usual care).

Being tested
Village doctor-led telemedicine integrated care, Enhanced usual care
Keywords
atrial fibrillation, integrated care, rural China, older, stroke
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Village doctor-led telemedicine integrated careOther

    1. Reorienting the model of care: using of telemedicine platform and online consulting clinic; 2. Coordinating services: contract service by village doctor and on-line AF specialist; 3. Empowering and engaging people: provide village doctor ABC pathway training course; regular visit and drug delivery by village doctor (community support); patients and their family members education.

  • Enhanced usual careOther

    1. Usual care; 2. Intensified education to patients, their family members, and their village doctors.
Study groups in NCT04622514
Study groupRoleWhat they receive
Village doctor-led telemedicine integrated careExperimentalTo empower village doctors, a new technology-based model of AF care was established in the intervention group. A digital health support platform was developed by our research team, and a network of teams consisting of village doctors and AF specialists in our research team was established in the intervention group. With the aid of this telemedicine platform, village doctors can receive more support from AF specialists in providing integrated AF care to the rural elderly with AF.
Receives: Other: Village doctor-led telemedicine integrated care
Enhanced usual careActive comparatorUsual care plus intensified education to patients, their family members, and their village doctors.
Receives: Other: Enhanced usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care

    The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'

    Measured: 12 months after baseline

  2. Primary Outcome of Stage 2: The composite of cardiovascular death, all stroke, worsening of heart failure or acute coronary syndrome, and emergency visits due to AF

    Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death. All strokes included ischemic stroke and hemorrhagic stroke. A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions

    Measured: 36 months after baseline

Secondary outcomes (11)

  1. Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the A component in the ABC pathway

    The 'A' criterion referred to stroke prevention or anticoagulation. Thus, 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'

    Measured: 12 months after baseline

  2. Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the B component in the ABC pathway

    The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an European Heart Rhythm Association (EHRA) score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled

    Measured: 12 months after baseline

  3. Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the C component in the ABC pathway

    The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'

    Measured: 12 months after baseline

  4. Secondary Outcome of Stage 2: All-cause mortality

    all-cause death

    Measured: 36 months after baseline

  5. Secondary Outcome of Stage 2: Cardiovascular death

    Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death

    Measured: 36 months after baseline

  6. Secondary Outcome of Stage 2: Ischemic or hemorrhagic Stroke

    All strokes: ischemic or hemorrhagic Stroke

    Measured: 36 months after baseline

  7. Secondary Outcome of Stage 2: Worsening of heart failure or acute coronary syndrome

    A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions

    Measured: 36 months after baseline

  8. Secondary Outcome of Stage 2: Emergency visit due to AF

    Emergency visit due to AF

    Measured: 36 months after baseline

  9. Secondary Outcome of Stage 2: Major bleeding

    Major bleeding was defined as fatal bleeding, bleeding in a critical area or organ, or clinically overt bleeding leading to a decrease in the hemoglobin level ≥2 g/dl or transfusion of ≥2 units of packed red cells

    Measured: 36 months after baseline

  10. Secondary Outcome of Stage 2: Clinically relevant non-major bleeding

    Clinically relevant non-major bleeding referred to bleeding that does not meet the criteria for the ISTH definition of major bleeding but is clinically overt bleeding associated with hospital admission, physician-guided medical or surgical treatment, or a change in antithrombotic therapy.

    Measured: 36 months after baseline

  11. Secondary Outcome of Stage 2: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care

    The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'

    Measured: 36 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start1 Dec 2020
  3. Primary completion9 May 2024
  4. Study completion30 May 2024

Resources

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
1,039 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04622514
Sponsor's protocol ID
2020-SR-027
Acronym
MIRACLE-AF
Status last verified
Jul 2024
First submitted
18 Oct 2020
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen Y, Yu Q, Gue Y, Meng Y, Zheng Y, Li M, Guo Y, Chen M, Lip GYH. Heterogeneity of Treatment Effect of ABC Pathway-Based Care in Older Atrial Fibrillation: Insights from the mAFA-II and MIRACLE-AF Trials Using a Causal Machine Learning Approach. Heart Rhythm. 2026 Oct 30:S1547-5271(26)02930-9. doi: 10.1016/j.hrthm.2026.10.059. Online ahead of print.

    PubMed 42963029

  • Li M, Chen Y, Zhang S, Chu M, Yang S, Shen Y, Lip GYH, Chen M. Cognitive Function and Telemedicine-based, Village Doctor-led Care for Atrial Fibrillation. Europace. 2026 Aug 28:euag233. doi: 10.1093/europace/euag233. Online ahead of print.

    PubMed 42663407

  • Li M, Chen Y, Chu M, Zhang S, Yang S, Lip GYH, Chen M. Village Doctor-Led Telemedicine for Rural Patients Aged 75 Years and Older With AF: A Prespecified Secondary Analysis of the MIRACLE-AF Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261385. doi: 10.1001/jamanetworkopen.2026.1385.

    PubMed 41817526

  • Chu M, Zhang S, Gong J, Yang S, Yang G, Sun X, Wu D, Xia Y, Jiao J, Peng X, Peng Z, Hong L, Wang Z, Li M, Lip GYH, Chen M; MIRACLE-AF Investigators. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21.

    PubMed 39984634

  • Li M, Chu M, Shen Y, Zhang S, Yin X, Yang S, Lip GYH, Chen M; MIRACLE-AF Trial Investigators. A Novel Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China. JACC Asia. 2024 Jul 30;4(10):764-773. doi: 10.1016/j.jacasi.2024.07.006. eCollection 2024 Oct.

    PubMed 39553909

Questions about this trial

What is this clinical trial studying?

A study testing Village doctor-led telemedicine integrated care in people with Atrial Fibrillation and Older, run by The First Affiliated Hospital with Nanjing Medical University 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care (time frame: 12 months after baseline). The study lists 2 primary outcomes in all. 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 NCT04622514, which also lists 5 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 26 Jul 2024.

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