Coronary Artery DiseaseHYCARETNCT03881150
Hybrid Cardiac Rehabilitation Trial
A study testing Comprehensive assessment, Counseling and Group education in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Universidad de La Frontera at 6 sites in Chile.
Trial summary
This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Comprehensive assessment, Counseling and Group education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 6 sitesChile
- Study dates
- 6 May 2019to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 year old or over.
- Patient with coronary artery disease, including Acute Coronary Syndrome (Unstable Angina, Myocardial infarction with or without ST elevation) or stable coronary vessel disease diagnosed by angiography or a stress test.
- Patient treated medically (i.e., medication only) or by thrombolysis, angioplasty, or revascularization surgery.
- Patient with physician referral, that can start CR between 2 weeks and 2 months from their event, diagnosis or procedure.
- Patient able to attend the health center almost twice a week over three months.
- Patient owns a mobile phone.
- Patient that consents to participate in the study through signing an informed consent form.
Who cannot join
- Patient has a planned repeat cardiac or other procedure in next 12 months.
- Explicit contraindication to perform exercise based on American College of Sport Medicine.
- Patients with comorbidities that would interfere with ability to engage in cardiac rehabilitation such as dementia, blindness, deafness, serious mental illness, or frailty.
- Musculoskeletal disease that precludes the patient from performing exercise
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Chile6 sites
Hospital Regional de Antofagasta
Antofagasta
Complejo Hospitalario San José
Santiago
Hospital Clínico Universidad de Chile
Santiago
Hospital San Borja Arriarán
Santiago
Hospital San Juan de Dios
Santiago
Universidad de La Frontera
Temuco, Araucania, 4781176
About this study
Official title: Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study
This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.
Read the detailed description
Background: Cardiac rehabilitation (CR) programs are well established, as their effectiveness and cost-effectiveness is proven. In spite of this, CR remains under-utilized, especially in middle and low-resource settings such as Latin America. As the highest rates of mortality and disability-adjusted life-years in the world are caused by cardiovascular diseases, with a corresponding major impact on economies, there is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid cardiac rehabilitation program compared to a standard program.
Method and analysis: A non-inferiority, pragmatic, multicenter, parallel (1:1), single blinded, randomized clinical trial will be conducted. 314 patients with coronary artery disease will be recruited consecutively. Participants will be randomized to hybrid or standard rehabilitation programs. The hybrid CR program includes 10 supervised exercise sessions and individualized lifestyle counseling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. The intervention in both groups will be by 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalizations due to cardiovascular causes. Secondary outcomes are cardiovascular risk factor control, exercise capacity, adherence to physical activity and diet recommendations, health-related quality of life and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months, and at 12-month follow-up from recruitment. The primary outcome will be tracked through the end of the trial. The sample size was calculated considering 5% of the non-inferiority limit. Per protocol and intention-to-treat analysis will be undertaken. A survival analysis will be run for the primary outcome.
Ethics and dissemination: The corresponding ethical committees at the sponsor institution and each center where participants will be recruited approved the study protocol and the Informed Consent form. Research findings will be published in peer-reviewed journals. Additionally, scientific results will be disseminated among stakeholders and national policy-makers.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Comprehensive assessment, Counseling, Group education, Exercise sessions in hybrid program, Exercise sessions in standard program
- Keywords
- Cardiac rehabilitation, Exercise, Coronary Artery Disease, Mobile technology
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive assessmentOther
Includes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart.
CounselingOther
Physical activity, diet, smoking, and medication compliance counseling will be provided by the physiotherapist across exercise sessions, using a self-efficacy approach. A booklet was designed in order to support the individual counseling.
Group educationOther
Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.
Exercise sessions in hybrid programOther
10 supervised exercise sessions over 4-6 weeks of aerobic and resistance training will ensue, supervised by a physiotherapist. Exercise sessions are 10 minutes in duration at the beginning of the program, and are progressed to 60 minutes by the end as tolerated.
Intensity of exercise will be moderate.
Exercise sessions in standard programOther
18-22 supervised exercise sessions are delivered over the 8-12 week program. These sessions include aerobic and resistance training and a similar progression of duration as the experimental group.
Intensity of exercise will be moderate.
Transition to unsupervised phaseOther
After 4-6 weeks with face-to-face exercise sessions in hybrid program, all patients will be monitored through mobile technology. Delivery methods will include voice calls biweekly, and text messaging three per week through to 10-12 weeks from program initiation. The content will promote physical activity, healthy diet, and medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Cardiac Rehabilitation | Experimental | This intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology.
Counseling is considered about physical activity, diet, smoking, and medication compliance. Receives: Other: Comprehensive assessment; Other: Counseling; Other: Exercise sessions in hybrid program; Other: Transition to unsupervised phase |
| Standard Cardiac Rehabilitation | Active comparator | The participants in the control group will receive the standard cardiac rehabilitation that is delivered in participating centers. These programs accounts with physicians, nurses, nutritionists and physiotherapists. The programs will be standardized in participating centers in accordance with currents guidelines (only 18-22 face-to-face exercise sessions). Differentially, this programs provide, group education sessions about physical activity, diet, smoking, and medication compliance (without counseling). Receives: Other: Comprehensive assessment; Other: Group education; Other: Exercise sessions in standard program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent cardiovascular events
Composite of cardiovascular mortality (defined as death by stroke, myocardial infarction or heart failure) and hospitalizations due to a cardiovascular cause (non-fatal stroke, non-fatal myocardial infarction, heart failure, and need for revascularization surgery)
Measured: 12 months (or more for first recruited participants, but until 36 months).
Secondary outcomes (11)
Health-related quality of life
HeartQoL as disease-specific and EuroQol five-dimensional three-level (EQ-5D-3L) as generic instrument will be administered
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
Functional exercise capacity
In meters (mts) obtained in the 6 Minute Walking Test
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Grip strength
In kilograms (kgs) obtained by dynamometry
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Adherence to physical activity recommendations
The International Physical Activity Questionnaire (IPAQ) will be administered. This instrument can quantify the energy spent in MET-minutes/week for categorization in accordance with the World Health Organization recommendation: An adults 18 years old or over adheres when perform 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous activity per week, or a combination of both.
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
Adherence to diet recommendations
Trained personnel will administer the Mediterranean Dietary Index for Chilean population (Chile-MDI). Participants recall the frequency of consumption of 14 food groups. This instrument had been validated. Scores range from 0 to 14 points, indicating absence and maximum adherence, respectively.
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
Return-to-work
Concordance between desired and actual work status at assessment
Measured: End of intervention (8-12 weeks), 6 months, and 12 months
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m2
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Waist circumference
In centimeters (cms)
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Blood Pressure
In millimeters of mercury (mmHg)
Measured: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Adherence
Percentage of attendance at supervised sessions planned. Also adherence to the calls in the intervention group will be collect.
Measured: End of intervention (8-12 weeks)
Exercise related adverse events
Counting adverse events during exercise, such as myocardial ischemia or malignant arrhythmias, will be registered. Serious adverse event, as death in the exercise session, will be registered and reported to corresponding ethic committee and monitor.
Measured: End of intervention (8-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start6 May 2019
- Primary completion5 Apr 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Serón, Universidad de La Frontera
- Investigators
- Pamela J Seron, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881150
- Sponsor's protocol ID
- Fondecyt 1181734
- Acronym
- HYCARET
- Status last verified
- May 2023
- First submitted
- 13 Mar 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
Publications
Seron P, Oliveros MJ, Marzuca-Nassr GN, Morales G, Roman C, Munoz SR, Galvez M, Latin G, Marileo T, Molina JP, Navarro R, Sepulveda P, Lanas F, Saavedra N, Ulloa C, Grace SL; HYCARET Investigators. Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350301. doi: 10.1001/jamanetworkopen.2023.50301.
PubMed 38194236Seron P, Oliveros MJ, Marzuca-Nassr GN, Lanas F, Morales G, Roman C, Munoz SR, Saavedra N, Grace SL. Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America. BMJ Open. 2019 Oct 28;9(10):e031213. doi: 10.1136/bmjopen-2019-031213.
PubMed 31662385
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study
- ClinicalTrials.gov ID
- NCT03881150
- Acronym / sponsor ID
- HYCARET / Fondecyt 1181734
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- Cardiac rehabilitation, Exercise, Coronary Artery Disease, Mobile technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 19 Mar 2019 (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.
This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.
Detailed description
Background: Cardiac rehabilitation (CR) programs are well established, as their effectiveness and cost-effectiveness is proven. In spite of this, CR remains under-utilized, especially in middle and low-resource settings such as Latin America. As the highest rates of mortality and disability-adjusted life-years in the world are caused by cardiovascular diseases, with a corresponding major impact on economies, there is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid cardiac rehabilitation program compared to a standard program.
Method and analysis: A non-inferiority, pragmatic, multicenter, parallel (1:1), single blinded, randomized clinical trial will be conducted. 314 patients with coronary artery disease will be recruited consecutively. Participants will be randomized to hybrid or standard rehabilitation programs. The hybrid CR program includes 10 supervised exercise sessions and individualized lifestyle counseling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. The intervention in both groups will be by 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalizations due to cardiovascular causes. Secondary outcomes are cardiovascular risk factor control, exercise capacity, adherence to physical activity and diet recommendations, health-related quality of life and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months, and at 12-month follow-up from recruitment. The primary outcome will be tracked through the end of the trial. The sample size was calculated considering 5% of the non-inferiority limit. Per protocol and intention-to-treat analysis will be undertaken. A survival analysis will be run for the primary outcome.
Ethics and dissemination: The corresponding ethical committees at the sponsor institution and each center where participants will be recruited approved the study protocol and the Informed Consent form. Research findings will be published in peer-reviewed journals. Additionally, scientific results will be disseminated among stakeholders and national policy-makers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Cardiac Rehabilitation | Experimental | Other: Comprehensive assessment, Other: Counseling, Other: Exercise sessions in hybrid program, Other: Transition to unsupervised phaseThis intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology. Counseling is considered about physical activity, diet, smoking, and medication compliance. |
| Standard Cardiac Rehabilitation | Active comparator | Other: Comprehensive assessment, Other: Group education, Other: Exercise sessions in standard programThe participants in the control group will receive the standard cardiac rehabilitation that is delivered in participating centers. These programs accounts with physicians, nurses, nutritionists and physiotherapists. The programs will be standardized in participating centers in accordance with currents guidelines (only 18-22 face-to-face exercise sessions). Differentially, this programs provide, group education sessions about physical activity, diet, smoking, and medication compliance (without counseling). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 year old or over.
- Patient with coronary artery disease, including Acute Coronary Syndrome (Unstable Angina, Myocardial infarction with or without ST elevation) or stable coronary vessel disease diagnosed by angiography or a stress test.
- Patient treated medically (i.e., medication only) or by thrombolysis, angioplasty, or revascularization surgery.
- Patient with physician referral, that can start CR between 2 weeks and 2 months from their event, diagnosis or procedure.
- Patient able to attend the health center almost twice a week over three months.
Key exclusion criteria (4 listed)
- Patient has a planned repeat cardiac or other procedure in next 12 months.
- Explicit contraindication to perform exercise based on American College of Sport Medicine.
- Patients with comorbidities that would interfere with ability to engage in cardiac rehabilitation such as dementia, blindness, deafness, serious mental illness, or frailty.
- Musculoskeletal disease that precludes the patient from performing exercise
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 |
|---|---|---|
| Comprehensive assessmentIncludes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart. | Other | Hybrid Cardiac Rehabilitation, Standard Cardiac Rehabilitation |
| CounselingPhysical activity, diet, smoking, and medication compliance counseling will be provided by the physiotherapist across exercise sessions, using a self-efficacy approach. A booklet was designed in order to support the individual counseling. | Other | Hybrid Cardiac Rehabilitation |
| Group educationGroup education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center. | Other | Standard Cardiac Rehabilitation |
| Exercise sessions in hybrid program10 supervised exercise sessions over 4-6 weeks of aerobic and resistance training will ensue, supervised by a physiotherapist. Exercise sessions are 10 minutes in duration at the beginning of the program, and are progressed to 60 minutes by the end as tolerated. Intensity of exercise will be moderate. | Other | Hybrid Cardiac Rehabilitation |
| Exercise sessions in standard program18-22 supervised exercise sessions are delivered over the 8-12 week program. These sessions include aerobic and resistance training and a similar progression of duration as the experimental group. Intensity of exercise will be moderate. | Other | Standard Cardiac Rehabilitation |
| Transition to unsupervised phaseAfter 4-6 weeks with face-to-face exercise sessions in hybrid program, all patients will be monitored through mobile technology. Delivery methods will include voice calls biweekly, and text messaging three per week through to 10-12 weeks from program initiation. The content will promote physical activity, healthy diet, and medication adherence. | Other | Hybrid Cardiac Rehabilitation |
Primary outcome
Recurrent cardiovascular events
Time frame: 12 months (or more for first recruited participants, but until 36 months).
Composite of cardiovascular mortality (defined as death by stroke, myocardial infarction or heart failure) and hospitalizations due to a cardiovascular cause (non-fatal stroke, non-fatal myocardial infarction, heart failure, and need for revascularization surgery)
11 secondary outcomes
Health-related quality of life
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
Functional exercise capacity
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Grip strength
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Adherence to physical activity recommendations
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
Adherence to diet recommendations
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
Return-to-work
Time frame: End of intervention (8-12 weeks), 6 months, and 12 months
Body Mass Index (BMI)
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Waist circumference
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Blood Pressure
Time frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
Adherence
Time frame: End of intervention (8-12 weeks)
Exercise related adverse events
Time frame: End of intervention (8-12 weeks)
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 10 May 2023.
- Derived from this study: PubMed 38194236Seron P, Oliveros MJ, Marzuca-Nassr GN, Morales G, Roman C, Munoz SR, Galvez M, Latin G, Marileo T, Molina JP, Navarro R, Sepulveda P, Lanas F, Saavedra N, Ulloa C, Grace SL; HYCARET Investigators. Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350301. doi: 10.1001/jamanetworkopen.2023.50301.
- Derived from this study: PubMed 31662385Seron P, Oliveros MJ, Marzuca-Nassr GN, Lanas F, Morales G, Roman C, Munoz SR, Saavedra N, Grace SL. Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America. BMJ Open. 2019 Oct 28;9(10):e031213. doi: 10.1136/bmjopen-2019-031213.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
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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.
Pamela J Seron, PhD principal investigator
Universidad de La Frontera
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive assessment, Counseling and Group education in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Universidad de La Frontera at 6 sites in Chile.
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 7 inclusion and 4 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Chile. 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?
Recurrent cardiovascular events (time frame: 12 months (or more for first recruited participants, but until 36 months).). 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 NCT03881150, which also lists 2 linked publications.
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 10 May 2023.