The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pulse wave velocity (PWV) I
研究概览
简要总结
Coronary heart disease, including acute coronary syndromes (ACS), is the leading cause of death in European countries. One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation.
The aims of the study are evaluation of the impact of cardiac rehabilitation on health state- especially on cardiovascular function parameters in patients after acute coronary syndrome and evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease on the course of cardiac rehabilitation in patients after ACS.
The study will consist of a retrospective and prospective part. The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation. In the retrospective part, patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention. The prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention.
After being included in the study, patients will undergo medical examination. Then subsequent procedures will be performed: anthropometric measurements; ECG; body composition analysis by bioimpedance; measurement of resting blood pressure, resting heart rate and oxygen saturation of hemoglobin; pulse wave analysis; transthoracic echocardiography of the heart; 24-hour blood pressure measurement by ambulatory blood pressure monitoring (ABPM); 24-hour ECG recording using the Holter method; electrocardiographic exercise test on a treadmill and / or a six-minute walk test or other exercise test adequate to the patient's state of health; assessment of the quality of the diet; assessment of lifestyle, acceptance of disease and quality of life; assessment of the psychological profile.
Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program.
After the cardiac rehabilitation program measurement procedures listed above will be repeated.
Before and after the cardiac rehabilitation program blood samples, urine samples and hair samples will be collected. Blood samples, urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study.
详细描述
Coronary heart disease, including acute coronary syndromes (ACS), is the leading cause of death in European countries, including Poland. In addition, it is one of the main causes of disability and the number of lost years of life and the number of years of life lost in good health. The costs of its treatment include not only the primary prophylaxis of cardiovascular events, the treatment of cardiovascular events, the treatment of chronic conditions and complications such as chronic heart failure or arrhythmia, but also the secondary and tertiary prophylaxis of acute coronary syndromes.
One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation. It should be implemented as soon as possible after the ACS and be part of a comprehensive, planned and systematic care of the patient after ACS. The beneficial effect of cardiac rehabilitation on the cardiovascular system, lipid and carbohydrate metabolism and physical performance has been demonstrated in a way that does not raise any doubts. However, in the light of the growing epidemic of civilization diseases such as excessive body mass, diabetes, dyslipidemia, hypertension and other cardiometabolic disorders, it is necessary to conduct high-quality research on the development of the most effective cardiac rehabilitation programs, so as to maximize their beneficial effect on patients' health.
The aims of the study are:
- Evaluation of the impact of cardiac rehabilitation on selected anthropometric, biochemical, mineral parameters, body composition parameters, physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome.
- Assessment of lifestyle, acceptance of disease, quality of life, diet and psychological profile and the influence of these factors on the course of cardiac rehabilitation in patients after acute coronary syndrome.
- Evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease and predisposing conditions (including excessive body weight, hypertension, lipid and carbohydrate disorders, impaired vascular endothelial function) on the course of cardiac rehabilitation in patients after acute coronary syndrome and searching for new genes that may affect the course of cardiac rehabilitation in this group of patients.
Research hypotheses:
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent in writing
- •Coronary heart disease, a state after an acute coronary syndrome
- •Female or male
- •Age 18 - 99 years
排除标准
- •Active neoplastic disease
- •Alcohol abuse, drug abuse
- •Pregnancy, lactation
- •Other conditions that in the opinion of researchers may pose any risk to the patient during the study.
结局指标
主要结局
Pulse wave velocity (PWV) I
时间窗: At baseline
Pulse wave velocity I
PWV II
时间窗: After intervention completion- an average of 2 weeks from baseline
Pulse wave velocity II
次要结局
- Metabolic equivalent (MET) I(At baseline)
- triglycerides (TG) I(At baseline)
- Aortic pressure (AP) I(At baseline)
- BM II(After intervention completion- an average of 2 weeks from baseline)
- BH II(After intervention completion- an average of 2 weeks from baseline)
- AP II(After intervention completion- an average of 2 weeks from baseline)
- Body height (BH) I(At baseline)
- Heart rate (HR) I(At baseline)
- HR II(After intervention completion- an average of 2 weeks from baseline)
- Distance in 6-minutes walk (6MW-D) I(At baseline)
- alanine aminotransferase (ALT) I(At baseline)
- direct bilirubin (DB) I(At baseline)
- DB II(After intervention completion- an average of 2 weeks from baseline)
- TCH II(After intervention completion- an average of 2 weeks from baseline)
- low density lipoprotein (LDL) I(At baseline)
- LDL II(After intervention completion- an average of 2 weeks from baseline)
- BMI II(After intervention completion- an average of 2 weeks from baseline)
- Body mass (BM) I(At baseline)
- Body mass index (BMI) I(At baseline)
- Hip circumference (HC) I(At baseline)
- Blood oxygen saturation (SO2) I(At baseline)
- AST II(After intervention completion- an average of 2 weeks from baseline)
- ALT II(After intervention completion- an average of 2 weeks from baseline)
- TB II(After intervention completion- an average of 2 weeks from baseline)
- INS II(After intervention completion- an average of 2 weeks from baseline)
- GLU II(After intervention completion- an average of 2 weeks from baseline)
- HC II(After intervention completion- an average of 2 weeks from baseline)
- Total fat percentage (TF%) I(At baseline)
- SBP II(After intervention completion- an average of 2 weeks from baseline)
- Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I(At baseline)
- ABPM DBP II(After intervention completion- an average of 2 weeks from baseline)
- GGTP II(After intervention completion- an average of 2 weeks from baseline)
- total cholesterol (TCH) I(At baseline)
- TG II(After intervention completion- an average of 2 weeks from baseline)
- creatinine (CREA) I(At baseline)
- CRP II(After intervention completion- an average of 2 weeks from baseline)
- NTpro-BNP II(After intervention completion- an average of 2 weeks from baseline)
- interleukin 6 (IL6) I(At baseline)
- ABPM SBP II(After intervention completion- an average of 2 weeks from baseline)
- Neck circumference (NC) I(At baseline)
- Waist circumference (WC) I(At baseline)
- WC II(After intervention completion- an average of 2 weeks from baseline)
- NC II(After intervention completion- an average of 2 weeks from baseline)
- Systolic blood pressure (SBP) I(At baseline)
- SO2 II(After intervention completion- an average of 2 weeks from baseline)
- Ejection fraction (EF) I(At baseline)
- 6MW-D II(After intervention completion- an average of 2 weeks from baseline)
- aspartate aminotransferase (AST) I(At baseline)
- high density lipoprotein (HDL) I(At baseline)
- HDL II(After intervention completion- an average of 2 weeks from baseline)
- insulin (INS) I(At baseline)
- ADR II(After intervention completion- an average of 2 weeks from baseline)
- homocysteine (Hcy) I(At baseline)
- DBP II(After intervention completion- an average of 2 weeks from baseline)
- EF II(After intervention completion- an average of 2 weeks from baseline)
- TF% II(After intervention completion- an average of 2 weeks from baseline)
- Diastolic blood pressure (DBP) I(At baseline)
- Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I(At baseline)
- MET II(After intervention completion- an average of 2 weeks from baseline)
- total bilirubin (TB) I(At baseline)
- indirect bilirubin (IB) I(At baseline)
- IB II(After intervention completion- an average of 2 weeks from baseline)
- gamma-glutamyltransferase (GGTP) I(At baseline)
- ApoA II(After intervention completion- an average of 2 weeks from baseline)
- N-terminal natriuretic propeptide type B (NTpro-BNP) I(At baseline)
- U-Mg II(After intervention completion- an average of 2 weeks from baseline)
- magnesium (Mg) I(At baseline)
- TROP II(After intervention completion- an average of 2 weeks from baseline)
- TNF II(After intervention completion- an average of 2 weeks from baseline)
- apolipoprotein A (ApoA) I(At baseline)
- glucose (GLU) I(At baseline)
- neopterin (NEOPT) I(At baseline)
- Hcy II(After intervention completion- an average of 2 weeks from baseline)
- VEGF II(After intervention completion- an average of 2 weeks from baseline)
- VEGF polymorphism(At baseline)
- adropin (ADR) I(At baseline)
- NEOPT II(After intervention completion- an average of 2 weeks from baseline)
- Mg II(After intervention completion- an average of 2 weeks from baseline)
- CREA II(After intervention completion- an average of 2 weeks from baseline)
- C-reactive protein (CRP) I(At baseline)
- troponin (TROP) I(At baseline)
- IL6 II(After intervention completion- an average of 2 weeks from baseline)
- tumor necrosis factor (TNF) I(At baseline)
- Urine concentration of magnesium (U-Mg) I(At baseline)
- LPT II(After intervention completion- an average of 2 weeks from baseline)
- vascular endothelial growth factor (VEGF) I(At baseline)
- leptin (LPT) I(At baseline)
- H-Mg II(After intervention completion- an average of 2 weeks from baseline)
- Hair content of magnesium (H-Mg) I(At baseline)
研究者
Damian Skrypnik
Principal Investigator and Study Manager; Doctor of Medicine
Poznan University of Medical Sciences