Cardiac Rehabilitation in Patients With Refractory Angina

NCT ID: NCT03218891

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2022-02-01

Brief Summary

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.

Detailed Description

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.

Conditions

Refractory Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical treatment physical training

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.

Group Type: EXPERIMENTAL

Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

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.

Optimized clinical treatment

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 Type: NO_INTERVENTION

No interventions assigned to this group

Coronary insufficiency without angina

Group with coronary insufficiency without angina and will not do physical training. They will do the tests only one moment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Normal healthy subjects

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cardiac Rehabilitation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Stable angina functional class II to IV according to the classification of Canadian Cardiovascular Society (CCS) 39, or limiting angina in Perception of the patient;
• Documented myocardial ischemia by imaging method;
• Patients not eligible for myocardial revascularization procedures surgical conventional, due to the unfavorable anatomy;
• Signature of the Free and Informed Consent Form.

• Patients with coronary insufficiency without angina;
• Signature of the Free and Informed Consent Form.

Group 4

• Signature of the Free and Informed Consent Form;
• Healthy;
• Non-smokers;
• Sedentary

Exclusion Criteria

• Patients with definitive pacemaker or implantable cardioverter defibrillator (ICD);
• Patients with non-sinus heart rhythm;
• Patients with complete intraventricular block;
• Acute coronary syndrome (myocardial infarction or unstable angina) or previous procedures for myocardial revascularization (angioplasty / surgery) less than 3 months;
• Functional impossibility (orthopedic, rheumatic, neurological, or otherwise) or social for participation in the Rehabilitation Program;
• Classification of risk for American Heart Association class D physical training (unstable ischemia, stenosis or severe or symptomatic valve insufficiency, congenital heart disease, decompensated heart failure, uncontrolled arrhythmias and other conditions that may be aggravated by exercise).

Group 3

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Instituto do Coracao

OTHER_GOV

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana Janot de Matos, Dra

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Luciana Janot de Matos, Dra

Role: PRINCIPAL_INVESTIGATOR

InCor Heart Institute

Locations

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

São Paulo, , Brazil

Countries

Brazil

References

de Assumpcao CRA, do Prado DML, Jordao CP, Dourado LOC, Vieira MLC, Montenegro CGSP, Negrao CE, Gowdak LHW, De Matos LDNJ. Cardiopulmonary exercise test in patients with refractory angina: functional and ischemic evaluation. Clinics (Sao Paulo). 2022 Feb 5;77:100003. doi: 10.1016/j.clinsp.2021.100003. eCollection 2022.

Reference Type: DERIVED

PMID: 35134662 (View on PubMed)

Other Identifiers

2014/00345-0

Identifier Type: -

Identifier Source: org_study_id