Changes in Specific miRNAs and Biochemical Biomarkers Following Personalized Cardiac Rehabilitation in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in miRNA Expression Levels
研究概览
简要总结
This prospective interventional study aims to investigate changes in specific microRNAs (miRNAs) and biochemical biomarkers following a personalized cardiac rehabilitation program in patients with coronary artery disease. A total of 46 participants aged 35-75 years who have undergone percutaneous coronary intervention or coronary artery bypass graft surgery and are eligible for cardiac rehabilitation will be included. Participants will complete a structured, individualized cardiac rehabilitation program lasting 6-8 weeks. Clinical assessments, cardiopulmonary exercise testing, and blood-based biomarker measurements will be performed before and after the rehabilitation program. The primary objective is to determine changes in miRNA and biochemical biomarker levels after cardiac rehabilitation and to evaluate the relationship between these changes and clinical improvement. The findings may contribute to a better understanding of biological responses to cardiac rehabilitation and support the development of more personalized rehabilitation strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable coronary artery disease
- •History of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- •Referred and considered clinically eligible for a structured cardiac rehabilitation program
- •Achievement of a respiratory quotient (RQ) of at least 1.0 during the baseline cardiopulmonary exercise test
- •Ability and willingness to participate in the study and complete the cardiac rehabilitation program
排除标准
- •Symptoms or signs of myocardial ischemia
- •Significant left ventricular outflow tract obstruction
- •Ventricular arrhythmia
- •Significant valvular heart disease
- •Uncontrolled hypertension
- •Severe comorbid conditions, including end-stage renal disease, advanced liver disease, or chronic inflammatory disease
- •Active malignancy
- •Physical limitations preventing full participation in exercise, including severe musculoskeletal disorders or major orthopedic or neurological comorbidities
- •Body mass index greater than 35 kg/m²
- •History of orthopedic surgery within the previous 6 months
- •Failure to comply with exercise testing or training procedures, or attendance of less than 80% of the rehabilitation program
- •Use of medications known to directly alter miRNA expression, such as certain immunosuppressive agents or chemotherapy drugs
- •Known psychiatric disorder
- •Presence of a permanent cardiac pacemaker
研究组 & 干预措施
Personalized Cardiac Rehabilitation Group
Participants will undergo a structured, individualized cardiac rehabilitation program lasting 6-8 weeks. Exercise intensity and workload will be prescribed according to each participant's baseline cardiopulmonary exercise test results, including peak oxygen uptake and maximal workload. The rehabilitation program will be tailored to the participant's clinical status and exercise capacity. Clinical assessments, cardiopulmonary exercise testing, and blood sampling for miRNA and biochemical biomarker analyses will be performed before and after completion of the rehabilitation program.
干预措施: Personalized Cardiac Rehabilitation Program (Behavioral)
结局指标
主要结局
Change in miRNA Expression Levels
时间窗: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Changes in the expression levels of miR-21, miR-126, miR-92a, miR-1, miR-155, and miR-133a will be assessed using quantitative real-time polymerase chain reaction (qRT-PCR) before and after completion of the cardiac rehabilitation program.
Change in Inflammatory, Cardiac, and Oxidative Stress Biomarkers
时间窗: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Changes in circulating levels of NT-proBNP, troponins, hs-CRP, IL-6, TNF-α, ST2, semaphorins, MDA, ADMA, and eNOS will be assessed before and after the cardiac rehabilitation program.
次要结局
- Change in Peak Oxygen Uptake (VO₂max)(Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program)
- Change in Maximum Exercise Workload(Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program)
- Change in Six-Minute Walk Test Distance(Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program)
- Change in Resting Heart Rate(Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program)
- Change in Maximum Heart Rate(Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program)
- Change in Health-Related Quality of Life(Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program)
研究者
Fatima Yaman
Assoc. Prof.
Kutahya Health Sciences University