Cardiac Rehabilitation in Patients With Refractory Angina

NCT03218891 | Completed DMC

• 1 other identifier: 2014/00345-0
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Angina

Keywords

Refractory Angina; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

  3 months of rehabilitation

• Cardiovascular rehabilitation in patients with refractory angina is efficient;

  Evaluated number of sore throat during the sessions.

  3 months of rehabilitation

• Improve the maximal oxygen consumption

  Improvement of Maximal oxygen uptake (VO2max)

  3 months of rehabilitation

• Improve the global myocardial ischemic load

  Reduction of myocardial ischemia, evidenced by improvement of the standard by effort echocardiography

  3 months of rehabilitation

Secondary Outcomes (8)

• Reduction of myocardial injury caused by physical stress

  3 months of rehabilitation

• Rehabilitation will modulate sympathetic activity

  3 months of rehabilitation

• Improvement of ventricular function

  3 months of rehabilitation

• Improvement of the quality of life

  3 months of rehabilitation

• Rehabilitation will increase muscle blood flow

  3 months of rehabilitation

Study Arms (4)

Clinical treatment physical training

EXPERIMENTAL

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

Optimized clinical treatment

NO INTERVENTION

Patients with optimized clinical treatment group that will not do physical training.They will do the tests in moment 1 and after 3 mounths.

Coronary insufficiency without angina

NO INTERVENTION

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

Normal healthy subjects

NO INTERVENTION

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.

Interventions

Cardiac Rehabilitation 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.

Clinical treatment physical training

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Instituto do Coracao: collaborator

Study Sites (1)

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

São Paulo, 05652-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35134662 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Luciana Janot de Matos, Dra

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Luciana Janot de Matos, Dra

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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); 4. Group normal healthy subjects

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: July 17, 2017
• Study Start: January 1, 2016
• Primary Completion: July 28, 2020
• Study Completion: February 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)