An interventional study of Cardiac Rehabilitation in Refractory Angina, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and feasibility of cardiovascular rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions of aerobic physical activity, evaluating the behavior during the training period; To evaluate the effect of rehabilitation on the modulation of sympathetic activity and inflammation, muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on ventricular function through Stress echocardiography; Detection of ischemic episodes and arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire, Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily sublingual nitrate intake.
After signing the informed consent form, patients will be randomized into 4 groups: 1. Optimized clinical treatment group + physical training for 12 weeks (TF); 2. optimized clinical treatment group (CT); 3. Group with coronary insufficiency without angina (CD); Group 4: normal healthy subjects All patients will be submitted to the following procedures in 2 moments * (times 0 and 3): -Routine laboratory tests including study of total cholesterol, LDL-cholesterol, -HDL-cholesterol, including study of the functionality of HDL-c, triglycerides, complete blood count, renal function, fasting glycemia, glycosylated hemoglobin (HbA1C); - Dosage of biomarkers of myocardial ischemia (ultra-sensitive troponin); - Dosage of inflammatory markers: Tumor necrosis factor (TNFn), interleukins 1 and 6 (IL-1 and IL-6), ultra-sensitive C-reactive protein (CRP); - Vascular endothelial growth factor (VEGF) dosage; - ergospirometric test in cycloergometer; - Echocardiogram with physical stress with evaluation of myocardial perfusion and function; - Evaluation of sympathetic activity through microneurography; - Evaluation of vascular reactivity through ultrasound of the brachial artery. - Evaluation of muscular blood flow through plethysmography; - Isometric exercise protocols; - Mental stress protocol - Quality of Life Questionnaire; - Diary of angina. After the initial examinations, the candidates of the TF group will be evaluated by cardiovascular rehabilitation team, for training prescription, which will be performed in a hospital environment, supervised by a qualified doctor. The rehabilitation may be interrupted in any patient, for safety measure, if the investigator deems it appropriate. All patients in both groups will receive clinical follow-up during the protocol, with monthly consultations during the 12-week protocol period (time 0 to 3), in which clinical evaluations of symptoms and quality of life of the patients will be performed . Any clinical intercurrence will be promptly annotated and evaluated according to the need of the moment. After this period, routine outpatient follow-up is scheduled at the outpatient clinic, and counseling for unsupervised physical training, according to the results of the study. All laboratory, clinical, imaging, and functional parameters will be evaluated before and at the end of the protocol.
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's enrollment of 72 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.
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Group 1 and 2
Inclusion Criteria:
Exclusion Criteria:
Group 3
Inclusion Criteria:
Group 4
Inclusion Criteria:
Patients with optimized clinical treatment group that will do physical training for 12 weeks. They will do the tests in moment 1 and after 3 mounths. The intervention is the Cardiac Rehabilitation.
Behavioral: Cardiac Rehabilitation
Patients with optimized clinical treatment group that will not do physical training.They will do the tests in moment 1 and after 3 mounths.
Group with coronary insufficiency without angina and will not do physical training. They will do the tests only one moment.
Group normal healthy subjects, without coronary injuries, diabetes, hypertension and another chronic disease. These group have be sedentary and will not do physical training. They will do the tests only one moment.
The physical training program will start shortly after the initial exams have been completed. The physical training protocol will consist of a 12-week duration, with a frequency of 3 weekly sessions of 60 minutes duration each. The intensity will be prescribed from the echocardiogram with effort and cardiopulmonary test. All sessions will be monitored by telemetry and will be distributed as follows: * 5 minutes warm up * 30 to 40 minutes of aerobic exercise (treadmill). The training intensity will be prescribed individually, based on the results of the test results; * 10 minutes of localized exercises; * 5 minutes of relaxation.
Cardiovascular rehabilitation in patients with refractory angina is safe;
Evaluated number of patients who have any kind of cardiovascular event during rehabilitation, as well as number of sore throat during the sessions.
Time frame: 3 months of rehabilitation
Cardiovascular rehabilitation in patients with refractory angina is efficient;
Evaluated number of sore throat during the sessions.
Time frame: 3 months of rehabilitation
Improve the maximal oxygen consumption
Improvement of Maximal oxygen uptake (VO2max)
Time frame: 3 months of rehabilitation
Improve the global myocardial ischemic load
Reduction of myocardial ischemia, evidenced by improvement of the standard by effort echocardiography
Time frame: 3 months of rehabilitation
Reduction of myocardial injury caused by physical stress
Improves levels of Troponin-T after 1 exercise session at the initial moment of the Protocol and after 3 months.
Time frame: 3 months of rehabilitation
Rehabilitation will modulate sympathetic activity
Decreased sympathetic nerve activity measured by the amount of shots in his microneurography
Time frame: 3 months of rehabilitation
Improvement of ventricular function
Improvement of ventricular function through stress echocardiography in patients undergoing rehabilitation
Time frame: 3 months of rehabilitation
Improvement of the quality of life
Improvement of the quality of life measured through the SF-36 questionnaire.
Time frame: 3 months of rehabilitation
Rehabilitation will increase muscle blood flow
Increase peripheral muscle blood flow measured by plethysmography.
Time frame: 3 months of rehabilitation
Reduction in the number of symptomatic episodes of ischemia
Reduction in the number of episodes of ischemia, reduction of daily sublingual nitrate intake.
Time frame: 3 months of rehabilitation
Reduction of the daily consumption of sublingual nitrate
Reduction of daily sublingual nitrate intake.
Time frame: 3 months of rehabilitation
Improve the functional class of Refractory Angina
Improve the functional class decrease of angina (according to Canadian Cardiovascular Society classification)
Time frame: 3 months of rehabilitation
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Hospital Israelita Albert Einstein