Effect of Digital Therapeutics for Cardiac Rehabilitation in Patients With Acute Myocardial Infarction

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how digital tools, like apps or online programs, can help patients recover after a heart attack, specifically those who have had a condition called Acute Myocardial Infarction (AMI). The study will take place at 14 hospitals, with Jiangsu Provincial People's Hospital leading the effort. It is not yet recruiting participants, but the trial aims to include adults aged 18 to 75 who have recently experienced a heart attack and have had a specific heart procedure called PCI (Percutaneous Coronary Intervention) for the first time. Participants should have a certain level of heart function and be able to understand and follow instructions.

Eligible participants can expect to use these digital tools to support their recovery, which may include exercises, educational materials, and progress tracking. However, there are several health conditions that could prevent someone from joining the study, such as severe heart problems, uncontrolled high blood pressure, or those who cannot use a smartphone. Before joining, patients will need to sign a consent form to participate in the trial. This study could help improve recovery options for heart attack patients by using technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient meets the diagnostic criteria for AMI in the "Diagnosis and Treatment Guidelines for Acute ST-Segment Elevation Myocardial Infarction (2019)" and undergoes PCI for the first time;
• • The age is between 18 and 75 years old;
• • The left ventricular ejection fraction (LVEF) is 35% - 50%;
• • The patient has normal cognition and can cooperate with the test;
• • The patient signs the informed consent and the agreement to participate in this study.
• Exclusion Criteria:
• * Symptom-limited cardiopulmonary exercise test (treadmill) contraindications:
• • 1. Uncontrolled acute coronary syndrome;
• • 2. Acute heart failure;
• • 3. Symptomatic severe aortic stenosis, severe aortic coarctation or descending aortic aneurysm;
• • 4. Acute aortic dissection;
• • 5. Acute myocarditis, pericarditis or endocarditis;
• • 6. Symptomatic or hemodynamically unstable severe arrhythmia;
• • 7. Severe bradyarrhythmia;
• • 8. Acute pulmonary embolism and pulmonary infarction;
• • 9. Acute respiratory failure;
• • 10. Uncontrolled asthma;
• • 11. Peripheral oxygen saturation \< 88% at rest or heart rate \> 120 beats/min;
• • s. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg; t. Recent stroke or transient ischemic attack; u. Intermuscular venous thrombosis of the lower extremities; v. Orthopedic injury that hinders walking; w. Mental abnormality; x. Those who cannot cooperate;
• • Patients who have not completed revascularization treatment or have planned revascularization within one year;
• • Pregnant or lactating patients, or those who plan to become pregnant within one year;
• • Patients who have received mechanical circulatory support treatment (such as intra-aortic balloon counterpulsation, Impella, ECMO, etc.) or tracheal intubation;
• • Patients with a history of non-ischemic cardiomyopathy such as viral myocarditis or dilated cardiomyopathy, hypertrophic cardiomyopathy, peripartum cardiomyopathy, etc.;
• • Patients with moderate or severe valvular heart disease or a history of valve replacement;
• • Severe liver function abnormality (ALT ≥ 3 times the upper limit of the normal range) or renal function abnormality (eGFR \< 60 mL/min/1.73 m2);
• • Patients with diseases such as malignant tumors and an expected lifespan of less than one year;
• • Those who cannot use a smartphone for various reasons and are inconvenient to communicate with the management team;
• • Those who are participating in other clinical trials;
• • The researcher believes that there are any other clinical conditions that are not suitable for inclusion in this study.