Study on Risk Early Warning of Clinical Prediction Model Based on Multi-Parameter Stress Perfusion Cardiac Magnetic Resonance in Adverse Prognosis of Dilated Cardiomyopathy
Conditions: Cardiomyopathy, Dilated, Prognosis, Magnetic Resonance Imaging, Cardiac, Death, Sudden, Cardiac, Heart Failure, Risk Assessment, Stress Perfusion
Sponsor: Shandong Provincial Hospital

STUDY DOCUMENT
Official Title: Study on Risk Early Warning of
Clinical Prediction Model Based on Multi-Parameter
Stress Perfusion Cardiac Magnetic Resonance in
Adverse Prognosis of Dilated Cardiomyopathy
NCT Number: Not available
Date of Document: October 30, 2025

1. Medical Subject Headings (MeSH) Terms
1.1 MeSH Headings for Conditions and Interventions
Studied
•
Cardiomyopathy, Dilated
•
Sudden Cardiac Death
•
Myocardial Microvascular Dysfunction
•
Magnetic Resonance Imaging, Cardiac
•
Myocardial Perfusion Imaging
•
Stress Perfusion
•
Implantable Cardioverter-Defibrillators
•
Cardiac Arrest
•
Heart Failure
•
Heart Transplantation
•
Left Ventricular Assist Devices
•
Myocardial Fibrosis
•
Coronary Artery Disease
•
Myocardial Perfusion Reserve
1.2 MeSH Check Tags
•
Humans
•
Adult
•
Middle Aged
•
Aged
•
Male
•
Female
•
Prospective Studies
•
Cohort Studies
•
Multicenter Studies
•
Observational Studies

2. Basic Study Information
Item
Content
Study Title
Study on Risk Early Warning
of Clinical Prediction Model
Based on MultiParameter
Stress Perfusion Cardiac
Magnetic Resonance in
Adverse Prognosis of Dilated
Cardiomyopathy
Study Type
Observational, Prospective,
Multicenter Cohort Study
Study Design
Prospective observational
cohort study; focusing on
evaluating the predictive value
of myocardial microvascular
dysfunction (MVD) assessed
by stress perfusion cardiac
magnetic resonance (CMR) for
SCD-related events (primary
endpoint) and secondary
endpoint events in patients
with DCM; artificial
intelligence (AI) will be
briefly used for auxiliary
analysis of CMR image
features without detailed
model development and
validation procedures.
Sample Size
Planned enrollment of ≥450
patients with DCM (recruited
from three study centers) to
ensure sufficient statistical
power for analyzing the
correlation between MVD and
SCD-related events.
Study Duration
Total study duration: 36
months (3 months of

preparation, 9 months of
recruitment and baseline
assessment, 24 months of
follow-up, 6 months of data
analysis and report writing)
Follow-up Period
24 months after baseline stress
perfusion CMR examination;
additional 6 months of follow-
up after the occurrence of the
primary endpoint event;
scheduled follow-up time
points: 3 months, 6 months, 12
months, 18 months, 24 months
post-CMR, and 1 year, 3 years,
5 years post-CMR for long-
term outcome observation.
Primary Endpoint
A composite of SCD-related
events, encompassing sudden
cardiac death (SCD),
appropriate implantable
cardioverter-defibrillator
(ICD) shock, and resuscitated
cardiac arrest (see Appendix
S1 for detailed diagnostic
criteria) .
Secondary Endpoint
A composite of heart failure–
related death, heart transplant,
and left ventricle (LV) assist
device implantation. Detailed
definitions: heart failure-
related death refers to death
associated with clinically
worsening heart failure
symptoms without evidence of
other causes; LV assist device
implantation follows FDA-
approved indications for
mechanical circulatory support
in severe heart failure
patients .

Registration Information
Planned to be registered on
ClinicalTrials.gov (NCT
number to be assigned)
Study Centers
Shandong Provincial Hospital,
Jinan Central Hospital, Beijing
Anzhen Hospital ; all centers
are tertiary grade A hospitals
with qualified 3.0T CMR
equipment, standardized stress
perfusion scanning protocols,
and experienced cardiology
and radiology teams to ensure
the accuracy and consistency
of MVD assessment.
3. Research Background and Significance
Dilated cardiomyopathy (DCM) is a common non-ischemic cardiomyopathy characterized by
left ventricular or biventricular dilation and reduced systolic function, which is a major cause
of sudden cardiac death (SCD) and heart failure in adults. The clinical prognosis of DCM is
highly heterogeneous, and identifying patients at high risk of SCD-related events remains a
critical clinical challenge, as traditional risk stratification tools have limited predictive
efficacy.
Myocardial microvascular dysfunction (MVD), defined as structural and functional
abnormalities of the coronary microcirculation (pre-arterioles and intramyocardial arterioles)
without significant epicardial coronary artery stenosis, has been increasingly recognized as an
important pathological feature of DCM. Previous studies have shown that DCM patients often
exhibit impaired myocardial perfusion reserve (MPR), a key indicator of MVD, which is
closely associated with the severity of left ventricular dysfunction and myocardial fibrosis.
Stress perfusion cardiac magnetic resonance (CMR) is a non-invasive, high-resolution
imaging technique that can accurately assess myocardial perfusion reserve and quantify MVD
by measuring stress and rest myocardial blood flow (MBF), with good correlation with
invasive microvascular function assessment indicators such as index of microvascular
resistance (IMR).
Notably, MVD may contribute to the pathogenesis of DCM through stress-induced repetitive
myocardial stunning and is closely related to adverse cardiac outcomes, including SCD.
However, the predictive value of MVD assessed by stress perfusion CMR for SCD-related
events in DCM patients has not been fully clarified, especially in a multicenter setting. Late
gadolinium enhancement (LGE) imaging is crucial for distinguishing ischemic from non-
ischemic etiologies, as infarct patterns of LGE are indicative of myocardial ischemia, which
needs to be excluded in DCM studies to ensure etiological purity and avoid confounding
effects on MVD assessment.

Conducted in three renowned tertiary hospitals (Shandong Provincial Hospital, Jinan Central
Hospital, Beijing Anzhen Hospital), this study aims to explore the correlation between MVD
(assessed by stress perfusion CMR) and SCD-related events in DCM patients, clarify the
predictive value of MVD for the primary endpoint, and provide a scientific basis for
individualized risk stratification and early warning of SCD in DCM patients. Artificial
intelligence (AI) will be briefly used for auxiliary extraction of CMR image features to
improve the efficiency of image analysis, without in-depth development and validation of AI
prediction models.
4. Research Objectives
4.1 Primary Objective
To evaluate the predictive value of myocardial microvascular dysfunction (MVD) assessed by
stress perfusion CMR for SCD-related events (SCD, appropriate ICD shock, resuscitated
cardiac arrest) in DCM patients, and confirm whether MVD is an independent risk factor for
the primary endpoint.
4.2 Secondary Objectives
•
To analyze the correlation between MVD severity (assessed by stress perfusion CMR
indicators) and the occurrence of secondary endpoint events (heart failure-related death, heart
transplant, LV assist device implantation).
•
To explore the relationship between MVD and other DCM-related indicators (left
ventricular structure and function, myocardial fibrosis, laboratory indicators such as NT-
proBNP), and clarify the potential mechanism of MVD in predicting SCD-related events.
•
To briefly apply AI technology for auxiliary extraction of stress perfusion CMR image
features, improving the efficiency and consistency of MVD assessment.
•
To establish a standardized method for MVD assessment using stress perfusion CMR in
DCM patients, providing a reference for clinical practice.
5. Study Subjects and Inclusion/Exclusion Criteria
5.1 Inclusion Criteria
1.
A diagnosis of DCM confirmed using the World Health Organization/International
Society and Federation of Cardiology (WHO/ISFC) criteria. The diagnosis is based on an
elevated left ventricular end-diastolic volume indexed to body surface area (LVEDV/BSA)
and reduced left ventricular ejection fraction (LVEF), compared with published age- and
gender-specific reference values . Reference values for LVEDV/BSA and LVEF are adopted
from internationally recognized guidelines to ensure diagnostic consistency.
2.
Age ＞18 years, regardless of gender.

3.
During the study period, were seen in the Cardiology Department of Shandong
Provincial Hospital, Jinan Central Hospital, or Beijing Anzhen Hospital, or referred for stress
perfusion CMR assessment.
4.
Able to understand and sign the informed consent form voluntarily, and can complete the
scheduled follow-up.
5.
Complete clinical data (including medical history, physical examination, laboratory tests,
electrocardiogram, etc.) are available.
5.2 Exclusion Criteria
1.
Presence of significant coronary artery disease (CAD), defined as a stenosis of >50% in a
major coronary artery. For left main coronary artery stenosis, a threshold of ≥50% is also
considered significant, consistent with clinical diagnostic criteria for CAD, to exclude the
impact of epicardial coronary stenosis on MVD assessment.
2.
Infiltrative diseases (e.g., cardiac amyloidosis, sarcoidosis) that may affect myocardial
structure and function and mimic DCM, as these diseases may independently cause MVD and
confound the study results.
3.
Valvular cardiomyopathy, which may cause ventricular dilation and systolic dysfunction
similar to DCM, and may be associated with secondary MVD.
4.
Presence of infarct patterns of LGE on CMR imaging. Infarct patterns of LGE are
defined as subendocardial enhancement corresponding to a coronary artery territory, which is
characteristic of ischemic myocardial injury; exclusion of such patients ensures that those
with ischemic etiologies are not included in the study, avoiding interference with the
assessment of MVD in non-ischemic DCM.
5.
Active malignant tumors, severe systemic infections, or other diseases that may affect the
study results and prognosis.
6.
Contraindications to CMR examination (such as pacemaker implantation, non-removable
metal implants, severe claustrophobia, allergy to gadolinium contrast agent, etc.) or
contraindications to stress perfusion (such as severe hypotension, severe asthma,
hypersensitivity to adenosine).
7.
Previous heart transplantation or left ventricular assist device (LVAD) implantation.
8.
Pregnant or lactating women (confirmed by pregnancy test).
9.
Unable to cooperate with CMR examination, follow-up, or data collection due to mental
illness, cognitive impairment, or other reasons.
10. Participating in other clinical trials that may affect the results of this study.
5.3 Exclusion Criteria After Enrollment (Withdrawal
Criteria)
1.
Found to not meet the inclusion criteria or meet any of the exclusion criteria after
enrollment.

2.
Lost to follow-up (no contact for more than 3 months, or failed to complete the
scheduled follow-up without reasonable reasons).
3.
Voluntarily requests to withdraw from the study (the right to withdraw at any time
without affecting subsequent medical treatment).
4.
Occurrence of severe adverse events that make it impossible to continue participating in
the study.
5.
Violation of the study protocol (such as refusing to complete CMR re-examination,
providing false information, etc.).
6. Study Process
6.1 Recruitment and Enrollment of Subjects
1.
Recruitment Sites: The study will be conducted in three tertiary grade A hospitals
(Shandong Provincial Hospital, Jinan Central Hospital, Beijing Anzhen Hospital). All centers
have qualified 3.0T CMR equipment, standardized stress perfusion scanning protocols, and
experienced cardiology and radiology teams to ensure the accuracy and consistency of MVD
assessment.
2.
Recruitment Methods: Subjects will be recruited through outpatient clinics, inpatient
wards, and referrals of the Cardiology Department of each research center. Researchers will
explain the purpose, process, potential risks, and benefits of the study to potential subjects in
detail, and provide written informed consent forms. Only those who fully understand and
voluntarily sign the informed consent form will be included in the study.
3.
Enrollment Process: After signing the informed consent form, subjects will undergo
baseline assessment (including clinical data collection, laboratory tests, electrocardiogram,
and stress perfusion CMR examination). Researchers will review the inclusion and exclusion
criteria again based on the assessment results, including confirmation of DCM diagnosis
according to WHO/ISFC criteria and exclusion of subjects with infarct patterns of LGE or
significant CAD. Qualified subjects will be assigned a unique study number, and relevant
information will be recorded in the case report form (CRF).
6.2 Baseline Assessment
1.
Clinical Data Collection: Researchers will collect general information (age, gender,
height, weight, body mass index [BMI], smoking history, drinking history, family history of
cardiovascular diseases, etc.), medical history (onset time, clinical symptoms, previous
treatment history, ICD implantation status if any, etc.), and medication history (type, dosage,
course of treatment, etc.) of subjects through questionnaires and medical record review.
2.
Laboratory Examinations: Venous blood will be collected from subjects on an empty
stomach (fasting for ≥8 hours) to detect indicators such as N-terminal pro-B-type natriuretic
peptide (NT-proBNP), troponin I/T, creatinine, liver function (alanine aminotransferase,
aspartate aminotransferase, total bilirubin), electrolytes (potassium, sodium, chlorine), and
fasting blood glucose. All tests will be performed by the clinical laboratory of each research

center in accordance with standard operating procedures (SOP).
3.
Electrocardiogram: Resting 12-lead electrocardiogram will be performed for all subjects
to record heart rate, rhythm, ST-T segment changes, and other indicators, which will be stored
and archived.
4.
Stress Perfusion CMR Examination (Key Assessment for MVD): All subjects will
undergo CMR examination using a 3.0T magnetic resonance scanner (consistent model across
all research centers). The examination includes two parts: ①Routine CMR sequences: Cine
imaging (for measuring left ventricular end-diastolic volume, end-systolic volume, LVEF, etc.,
and calculating LVEDV/BSA for DCM diagnosis), T1 mapping, T2 mapping, and LGE
imaging (for detecting myocardial fibrosis and identifying infarct patterns to exclude ischemic
etiologies); ②Stress perfusion CMR: Adenosine (140 μg/kg/min) will be infused to induce
myocardial stress, and first-pass perfusion imaging will be performed before and after stress
to measure myocardial blood flow (MBF) at rest and during stress. Myocardial perfusion
reserve (MPR) will be calculated as the ratio of stress MBF to rest MBF, with MPR < 2.0
defined as MVD according to established diagnostic criteria. Scanning parameters will be
standardized across all research centers to ensure the consistency of image quality. CMR
images will be stored in DICOM format for subsequent analysis. Two independent
radiologists (with more than 5 years of experience in cardiac imaging) will review LGE
images to confirm the absence of infarct patterns and independently assess MVD severity
based on MPR values, with consensus reached through discussion in case of discrepancies. AI
technology will be briefly used for auxiliary extraction of perfusion image features to improve
the efficiency of MPR calculation, without in-depth model optimization.
6.3 Follow-up
1.
Follow-up Frequency and Time Points: Follow-up will be conducted at 3 months, 6
months, 12 months, 18 months, and 24 months after baseline stress perfusion CMR
examination. For subjects who experience the primary or secondary endpoint event,
additional follow-up will be conducted for 6 months to record the recovery and long-term
prognosis after the event. In addition, long-term follow-up will be conducted at 1 year, 3 years,
and 5 years post-CMR to observe long-term outcomes.
2.
Follow-up Methods: A combination of outpatient follow-up, telephone follow-up, and
medical record review will be used. At each follow-up, researchers will record the occurrence
of endpoint events (in detail for SCD-related events and secondary endpoint events), changes
in clinical symptoms, medication adjustments, re-examination results (NT-proBNP,
electrocardiogram, and CMR re-examination if necessary), and adverse events. For subjects
with MVD at baseline, changes in MVD severity will be assessed by stress perfusion CMR
re-examination at 12 and 24 months if clinically feasible.
3.
Endpoint Event Judgment: An endpoint event judgment committee composed of 3 senior
cardiologists will be established to review and confirm the occurrence of endpoint events. The
committee will make a judgment based on medical records, examination results, and follow-
up records, referring to the diagnostic criteria in Appendix S1 for SCD-related events , to
ensure the accuracy and objectivity of the data. For SCD, the definition is death due to cardiac
causes occurring within 1 hour of symptom onset with sudden loss of consciousness ; for

appropriate ICD shock, it refers to shocks delivered in response to hemodynamically unstable
ventricular tachycardia or fibrillation without reversible causes ; for resuscitated cardiac arrest,
it refers to a cardiac arrest event reversed by cardiopulmonary resuscitation, defibrillation, or
pacing .
6.4 Data Collection and Management
1.
Data Collection: Researchers will fill in the CRF truthfully and completely according to
the baseline assessment and follow-up results, with special emphasis on recording stress
perfusion CMR indicators (rest MBF, stress MBF, MPR) and the occurrence of SCD-related
events. CMR images, laboratory test reports, electrocardiograms, endpoint event records, and
other relevant data will be archived in a unified manner.
2.
Data Verification: The data management team will conduct double-entry and verification
of the CRF data to correct errors and missing information in a timely manner. The
completeness, accuracy, and consistency of MVD-related data and endpoint event records will
be checked regularly (once a month) during the study period.
3.
Data Storage: All study data (including CRF, CMR images, laboratory test results, and
follow-up records) will be stored in a dedicated computer with password protection and data
encryption to ensure the confidentiality and security of subjects' personal information. The
data retention period will be at least 5 years after the end of the study, in accordance with
relevant national regulations and ethical requirements.
4.
Data Sharing: Individual participant data (IPD) will not be made available to external
researchers. The dataset contains sensitive clinical, imaging, and longitudinal prognostic
information from patients with DCM. Broad sharing of IPD may compromise patient privacy
and confidentiality, violate informed consent restrictions, and increase the risk of re-
identification. Therefore, IPD will be retained securely within the study group and will not be
shared externally.
7. Auxiliary AI Application (Brief)
Artificial intelligence technology will be applied to support the analysis of stress perfusion
CMR datasets, including automated image feature extraction and model construction.
Professional image processing software incorporating basic artificial intelligence algorithms
will be utilized to assist with left ventricular segmentation and the extraction of perfusion-
related imaging features, such as signal intensity upslope gradients during gadolinium first-
pass perfusion imaging. These features will support the calculation of resting myocardial
blood flow (MBF), stress MBF, and myocardial perfusion reserve (MPR), with the goal of
improving the efficiency and reproducibility of microvascular dysfunction (MVD) assessment.
Subsequent large-scale development, optimization, and independent validation of artificial
intelligence models will be performed in this study. The primary objective remains the
evaluation of the predictive value of MVD, as assessed by stress perfusion CMR, for sudden
cardiac death (SCD)–related adverse events.

8. Quality Control
1.
Personnel Training: Before the start of the study, all researchers, radiologists, data
managers, and study coordinators will receive unified training on the study protocol, SOP,
data collection requirements, endpoint event judgment criteria, stress perfusion CMR
scanning and MVD assessment standards, and ethical norms to ensure the consistency of
operation.
2.
CMR Quality Control: All research centers will use 3.0T magnetic resonance scanners of
the same model, and the scanning parameters (including stress perfusion sequences) will be
standardized. A professional CMR quality control team will regularly check the image quality
(once every 3 months); unqualified images will be re-scanned if necessary, and subjects who
cannot complete the stress perfusion CMR examination will be excluded from the study. The
consistency of MVD assessment by radiologists will be tested using Kappa analysis, with
Kappa value ≥0.80 required to ensure reliability.
3.
Data Quality Control: The data management team will conduct regular inspections of the
CRF data, with special focus on MVD-related indicators and endpoint event records, and any
problems found will be fed back to the researchers in a timely manner for correction. The
final data will be locked after verification to prevent data tampering. A random sample of
10% of the CRF data will be reviewed by the study leader to ensure data quality.
4.
Ethical Supervision: The Ethics Committee of each research center will supervise the
entire study process, review the study protocol and informed consent form regularly, and
handle adverse events and ethical issues in a timely manner to ensure that the study is carried
out in accordance with ethical principles.
9. Ethical Considerations
1.
Informed Consent: All subjects will sign the informed consent form voluntarily after
fully understanding the purpose, process, potential risks, and benefits of the study. The
informed consent form will be provided in both Chinese and English (if necessary) to ensure
that subjects can understand the content. Subjects have the right to ask questions about the
study, and researchers will answer truthfully.
2.
Confidentiality of Subject Information: The personal information of subjects (such as
name, ID number, contact information) will be encrypted and stored, and will not be disclosed
to any third party. The study data will be used only for scientific research purposes, and the
identity of subjects will be anonymized during data analysis.
3.
Risk Management: During the study, if subjects experience adverse events related to the
study (such as contrast agent allergy during CMR examination, hypotension during adenosine
infusion for stress perfusion), researchers will take timely and effective medical measures to
ensure the safety of subjects. All adverse events will be recorded in detail and reported to the
Ethics Committee and the study leader within 24 hours. For subjects with high risk of SCD-
related events identified during follow-up (especially those with severe MVD), researchers
will promptly inform the treating physician to adjust the treatment plan (e.g., considering ICD
implantation).

4.
Voluntary Withdrawal: Subjects have the right to withdraw from the study at any time
without any reason, and their medical treatment will not be affected. The data of subjects who
withdraw from the study will be retained and included in the final data analysis (unless the
subject requests to delete the data).
10. Statistical Analysis
Statistical analysis will be performed using SPSS 26.0 and R software (version 4.2.0).
Measurement data will be expressed as mean ± standard deviation (SD) if normally
distributed, or median (interquartile range, IQR) if abnormally distributed; comparison
between groups will be performed using t-test, non-parametric test (Mann-Whitney U test,
Kruskal-Wallis test) as appropriate. Count data will be expressed as rate (%) and compared
using χ² test or Fisher's exact test. The Kaplan-Meier method will be used to draw the survival
curve of subjects (for endpoint events), and the log-rank test will be used to compare the
event rate between DCM patients with and without MVD. Multivariate Cox proportional
hazards regression model will be used to screen the independent risk factors for SCD-related
events and secondary endpoint events, with MVD (assessed by stress perfusion CMR) as the
key independent variable. The receiver operating characteristic (ROC) curve will be used to
evaluate the predictive efficacy of MVD for SCD-related events, and the AUC value will be
calculated. P < 0.05 will be considered statistically significant. Subgroup analysis will be
performed based on age, gender, LVEF, and MVD severity to explore the predictive value of
MVD in different subgroups.
11. Study Schedule
Study Stage
Time Arrangement
(Months)
Key Tasks
Preparation Stage
1–3
Finalize the study protocol,
train researchers and related
personnel (focusing on
stress perfusion CMR
scanning and MVD
assessment), standardize
CMR scanning parameters,
establish the data
management system, design
Appendix S1 (diagnostic
criteria for SCD-related
events), and obtain ethical
approval from each research
center.

Recruitment and Baseline
Assessment Stage
4–12
Recruit subjects, conduct
baseline assessment
(clinical data collection,
laboratory tests,
electrocardiogram, stress
perfusion CMR
examination), review
inclusion/exclusion criteria,
assess MVD using stress
perfusion CMR (with brief
AI auxiliary analysis), and
complete data entry and
verification.
Follow-up Stage
13–36
Conduct regular follow-up,
record endpoint events and
adverse events, perform
stress perfusion CMR re-
examination at 12 and 24
months (if feasible) to
assess changes in MVD
severity, update study data,
and conduct long-term
follow-up at 1 year, 3 years,
and 5 years post-CMR.
Data Analysis and Report
Writing Stage
31–36
Conduct statistical analysis
of the study data (focusing
on the correlation between
MVD and SCD-related
events), sort out the study
results, write the study
report and Appendix S1,
and submit the report to the
Ethics Committee and
relevant departments.
12. Adverse Event Management
12.1 Definition of Adverse Events
Any untoward medical occurrence in a subject during the study period, regardless of whether
it is related to the study, including but not limited to: adverse reactions caused by CMR
examination (contrast agent allergy, claustrophobia attack, etc.), adverse reactions related to

stress perfusion (hypotension, bradycardia, asthma attack due to adenosine infusion),
deterioration of DCM-related symptoms (worsening heart failure, arrhythmia, etc.), and other
unexpected medical events (infection, accidental injury, etc.). Endpoint events (SCD-related
events, secondary endpoint events) are not classified as adverse events but are recorded
separately.
12.2 Reporting of Adverse Events
Researchers will record the occurrence time, type, severity, handling measures, and outcome
of adverse events in detail in the CRF. Mild and moderate adverse events will be reported to
the study leader and the Ethics Committee within 24 hours; severe adverse events (such as
death, severe allergy requiring emergency treatment, severe hypotension unresponsive to
treatment) will be reported immediately (within 2 hours) to the study leader and the Ethics
Committee, and a follow-up report will be submitted after the event is handled.
12.3 Handling of Adverse Events
For adverse events related to the study, researchers will take timely and effective medical
measures to treat the subjects, reduce the impact of adverse events, and closely observe the
recovery of the subjects. If the adverse event is severe and cannot be controlled, the subject
will be withdrawn from the study, and follow-up medical treatment will be arranged to ensure
the safety of the subject. For adverse reactions related to adenosine infusion during stress
perfusion, infusion will be stopped immediately, and symptomatic treatment (such as fluid
replacement, atropine administration for bradycardia) will be given.
13. Study Termination
1.
Voluntary Termination: The study leader may terminate the study voluntarily if the study
objectives are achieved in advance, or if serious safety problems, ethical issues, or other
unexpected factors that affect the study progress occur during the study.
2.
Termination by the Ethics Committee: The Ethics Committee may terminate the study if
it finds that the study does not comply with ethical principles, or if the risks to the subjects
exceed the benefits.
3.
Termination Due to Other Reasons: The study may be terminated due to insufficient
funding, difficulty in recruiting subjects (failure to reach the planned sample size within the
scheduled time), or changes in national policies and regulations.
4.
Disposal After Termination: After the study is terminated, the data collected will be
sorted out and analyzed, and a study termination report will be written and submitted to the
Ethics Committee and relevant departments. The follow-up of the subjects will be continued
if necessary to ensure their safety and rights.
14. Study Team and Responsibilities
1.
Principal Investigator (PI): Responsible for the overall design and implementation of the

study, coordinating the work of each research center, making important decisions related to
the study, and ensuring the scientificity and ethicality of the study, especially the
standardization of MVD assessment using stress perfusion CMR.
2.
Co-Investigators: Responsible for subject recruitment, baseline assessment, follow-up,
and data collection at each research center, ensuring the accuracy and completeness of MVD-
related data and endpoint event records, and reporting adverse events and endpoint events in a
timely manner.
3.
Sub-Investigators: Assist the co-investigators in completing the study work, including
data entry, sample collection, and follow-up visits.
4.
Radiologists: Responsible for stress perfusion CMR image acquisition, image quality
control, MVD assessment (based on MPR values), and LGE image review to exclude infarct
patterns, ensuring the reliability of CMR and MVD data; briefly use AI software for auxiliary
image feature extraction.
5.
Data Managers: Responsible for data entry, verification, storage, and management,
ensuring the confidentiality, integrity, and security of the data, with special focus on MVD-
related indicators and endpoint event records.
6.
Statisticians: Responsible for the design of the statistical analysis plan, statistical analysis
of the study data (focusing on the correlation between MVD and SCD-related events), and
providing technical support for the study results.
7.
Study Coordinators: Responsible for the daily management of the study, coordinating
communication between the research team and subjects, and ensuring the smooth progress of
the study.
8.
Ethics Committee: Responsible for reviewing the study protocol and informed consent
form, supervising the ethical conduct of the study, and protecting the rights and interests of
the subjects.
9.
Endpoint Event Judgment Committee: Composed of 3 senior cardiologists, responsible
for reviewing and confirming the occurrence of primary and secondary endpoint events,
ensuring the accuracy and consistency of endpoint event judgment.
15. Investigator Official Titles
Role
Investigator Official Title
Principal Investigator
Principal Investigator,
Department of Cardiology,
[Hospital Name]; Chief
Physician; Professor
Co-Investigator
Co-Investigator, Department of
Cardiology, [Hospital Name];
Associate Chief Physician;

Associate Professor
Sub-Investigator
Sub-Investigator, Department
of Cardiology, [Hospital
Name]; Attending Physician
Radiologist
Chief Radiologist / Cardiac
Imaging Specialist,
Department of Radiology,
[Hospital Name] (proficient in
stress perfusion CMR and
MVD assessment)
Study Coordinator
Study Coordinator,
Department of Cardiology,
[Hospital Name]
Statistician
Statistician, Department of
Biostatistics, [Hospital Name]
/ [Research Institute]
Appendix S1: Diagnostic Criteria for SCD-Related
Events
1.
Sudden Cardiac Death (SCD): Death due to cardiac causes occurring within 1 hour of the
onset of acute cardiac symptoms, characterized by sudden loss of consciousness. For
unwitnessed deaths with clear evidence of cardiac etiology, it is classified as probable SCD .
2.
Appropriate Implantable Cardioverter-Defibrillator (ICD) Shock: Shocks delivered by an
ICD in response to hemodynamically unstable ventricular tachycardia (VT) or ventricular
fibrillation (VF) that is not caused by reversible factors (such as electrolyte imbalance, drug
effects) .
3.
Resuscitated Cardiac Arrest: A cardiac arrest event that is reversed, usually by
cardiopulmonary resuscitation (CPR), defibrillation, cardioversion, or cardiac pacing, with
restoration of spontaneous circulation .