Skip to content

Clinical trial of safety and efficacy of pulse electromagnetic field therapy on myocardial ischemia

Clinical trial of safety and efficacy of pulse electromagnetic field therapy on myocardial ischemia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052189
Enrollment
Unknown
Registered
2021-10-22
Start date
2021-12-06
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myocardial ischemia in patients with coronary heart disease

Interventions

Experimental group:pulse electromagnetic field therapy + conventional therapy of myocardial ischemia
Control group:pulse electromagnetic field placebo therapy + conventional therapy of myocardial ischemia

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 to 75 years (inclusive), any gender. 2.During the screening period or within the past year, individuals who have undergone coronary angiography (CAG) or coronary computed tomography angiography (CTCA), with no current indication for coronary revascularization or patients unwilling or unable to undergo coronary revascularization. 3.Within the past year before screening, coronary angiography (CAG) or coronary computed tomography angiography (CTCA) showing stenosis of any major coronary vessels (left main, left anterior descending, circumflex, right coronary, diagonal, obtuse marginal, posterior descending, left ventricular posterior branch, etc.) with a luminal diameter greater than 2.5mm, and the degree of stenosis is 80% or less, with corresponding symptoms of myocardial ischemia. 4.Positron emission tomography (PET) showing local myocardial blood flow at rest =2.0ml/min/g (according to the 17-segment model/AHA model, involving at least 2 segments). 5.Echocardiography within the past 6 months showing left ventricular ejection fraction =40%. 6.Ability to tolerate a cardiopulmonary exercise test. 7.Informed consent and signing of a written informed consent form are required.

Exclusion criteria

Exclusion criteria: 1. Severe anemia (hemoglobin 150 beats/min), severe hypertension (systolic blood pressure >200 mmHg and diastolic blood pressure >110mmHg); 5. Severe lung disease, such as FEV1 35kg/m2); 7. Pregnant, breastfeeding, or planning to become pregnant during the trial; 8. Severe arrhythmia (ventricular tachycardia, ventricular fibrillation, frequent premature ventricular beats (24h dynamic cardiogram > 10,000 beats or common ECG prompts frequent premature ventricular beats), persistent atrial fibrillation, 2 degrees or 3 atrioventricular block, etc.); 9. Epilepsy; 10. Myocardial infarction, acute coronary syndrome, PCI or cardiac surgery within 90 days before screening; 11. Other researchers think that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Local Myocardial blood flow during chemical stress;

Secondary

MeasureTime frame
Coronary Flow Reserve;Area and severity of myocardial ischemia with rest and stress;Seattle Angina Scale Score;New York Heart Function Classification;Cardiopulmonary exercise test indicators;fasting blood sugar;Insomnia Severity Index Scale;

Countries

China

Contacts

Public ContactGe Junbo

Zhongshan Hospital Affiliated to Fudan University

Ge.junbo@zs-hospital.sh.cn+86 139 0197 7506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026