Refractory AnginaNCT03218891
Cardiac Rehabilitation in Patients With Refractory Angina
A study testing Cardiac Rehabilitation in people with Refractory Angina, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractory Angina
- What is being tested?
- Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2016to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- Group 4
- Signature of the Free and Informed Consent Form;
- Healthy;
- Non-smokers;
- Sedentary
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
São Paulo, 05652-000
About this study
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.
Read the 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
- Being tested
- Cardiac Rehabilitation
- Keywords
- Refractory Angina, Rehabilitation
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months of rehabilitation
Cardiovascular rehabilitation in patients with refractory angina is efficient;
Evaluated number of sore throat during the sessions.
Measured: 3 months of rehabilitation
Improve the maximal oxygen consumption
Improvement of Maximal oxygen uptake (VO2max)
Measured: 3 months of rehabilitation
Improve the global myocardial ischemic load
Reduction of myocardial ischemia, evidenced by improvement of the standard by effort echocardiography
Measured: 3 months of rehabilitation
Secondary outcomes (8)
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.
Measured: 3 months of rehabilitation
Rehabilitation will modulate sympathetic activity
Decreased sympathetic nerve activity measured by the amount of shots in his microneurography
Measured: 3 months of rehabilitation
Improvement of ventricular function
Improvement of ventricular function through stress echocardiography in patients undergoing rehabilitation
Measured: 3 months of rehabilitation
Improvement of the quality of life
Improvement of the quality of life measured through the SF-36 questionnaire.
Measured: 3 months of rehabilitation
Rehabilitation will increase muscle blood flow
Increase peripheral muscle blood flow measured by plethysmography.
Measured: 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.
Measured: 3 months of rehabilitation
Reduction of the daily consumption of sublingual nitrate
Reduction of daily sublingual nitrate intake.
Measured: 3 months of rehabilitation
Improve the functional class of Refractory Angina
Improve the functional class decrease of angina (according to Canadian Cardiovascular Society classification)
Measured: 3 months of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Jan 2016
- Primary completion28 Jul 2020
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto do Coracao
- Responsible party
- Sponsor
- Investigators
- Luciana Janot de Matos, Dra, Principal investigator, Hospital Israelita Albert EinsteinLuciana Janot de Matos, Dra, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218891
- Sponsor's protocol ID
- 2014/00345-0
- Other IDs
- 2014
- Status last verified
- Mar 2020
- First submitted
- 5 Jun 2017
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35134662
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation in Patients With Refractory Angina
- ClinicalTrials.gov ID
- NCT03218891
- Acronym / sponsor ID
- 2014/00345-0
- Conditions
- Refractory Angina
- Keywords
- Refractory Angina, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto do Coracao
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Clinical treatment physical training | Experimental | Behavioral: Cardiac RehabilitationPatients 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. |
| 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac RehabilitationThe 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. | Behavioural | Clinical treatment physical training |
Primary outcome
Cardiovascular rehabilitation in patients with refractory angina is safe;
Time frame: 3 months of rehabilitation
Evaluated number of patients who have any kind of cardiovascular event during rehabilitation, as well as number of sore throat during the sessions.
Cardiovascular rehabilitation in patients with refractory angina is efficient;
Time frame: 3 months of rehabilitation
Evaluated number of sore throat during the sessions.
Improve the maximal oxygen consumption
Time frame: 3 months of rehabilitation
Improvement of Maximal oxygen uptake (VO2max)
Improve the global myocardial ischemic load
Time frame: 3 months of rehabilitation
Reduction of myocardial ischemia, evidenced by improvement of the standard by effort echocardiography
8 secondary outcomes
Reduction of myocardial injury caused by physical stress
Time frame: 3 months of rehabilitation
Rehabilitation will modulate sympathetic activity
Time frame: 3 months of rehabilitation
Improvement of ventricular function
Time frame: 3 months of rehabilitation
Improvement of the quality of life
Time frame: 3 months of rehabilitation
Rehabilitation will increase muscle blood flow
Time frame: 3 months of rehabilitation
Reduction in the number of symptomatic episodes of ischemia
Time frame: 3 months of rehabilitation
Reduction of the daily consumption of sublingual nitrate
Time frame: 3 months of rehabilitation
Improve the functional class of Refractory Angina
Time frame: 3 months of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 35134662de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Janot de Matos, Dra principal investigator
Hospital Israelita Albert Einstein
Luciana Janot de Matos, Dra principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation in people with Refractory Angina, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular rehabilitation in patients with refractory angina is safe; (time frame: 3 months of rehabilitation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.