Chronic Stable AnginaNOVA-SKINNCT02591758
Novel Vitality Indices Derived From the Hexoskin in Patients Affected With Angina Undergoing Coronary Revascularization or Medical Therapy
An observational study of Chronic Stable Angina, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The first and foremost manifestation of ischemic heart disease (IHD) is angina. At a global level, patients with chronic angina are at risk of poor vital status and deconditioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Hexoskin Vest, Cardiac rehabilitation program and Anxiety assessment as determined by the GAD-7
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2015to 17 Jul 2018
- Phase
- Observational
- 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
Study population: Thirty (30) subjects who meet all of the inclusion criteria and none of the exclusion criteria and who successfully wear the Hexoskin vest in the run-in will be eligible to study participation. Subjects will be recruited as outpatient, from the specialized angina clinic at the Montreal Heart Institute (MHI) or as an inpatient, after screening by the research team.
Who may be able to join
- Written informed consent form
- Patient 18 years of age
- History of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) of myocardial infarction or significant coronary artery disease with non-invasive angiographic confirmation.
- Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes.
- All-comers with stable or unstable moderate-to-severe angina pectoris (Canadian Cardiovascular Class [CCS] II-III or IV subsequently medically stabilized (minimum 7 days) despite guideline directed medical therapy due to a reversible myocardial ischemia deemed sufficiently severe to justify a coronary angiography.
- Patient can be treated percutaneously, surgically or medically.
- Willing to undertake a cardiac rehabilitation program at home
- Patient understands the nature of the device and is able to wear the Hexoskin for 24h Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Who cannot join
- Recent (<1 week) acute coronary syndrome
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the 3 months prior to screening.
- Severe valvular disease
- High-risk criteria demonstrated on the treadmill stress test (Appendix D5)
- With contraindications to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform treadmill stress test (including but not limited to : pulmonary hypertension, functionally limiting chronic obstructive pulmonary disease (COPD), history of pulmonary tuberculosis, prior hospitalization for acute exacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapy that can limit exercise capacity, functionally limiting peripheral artery disease.
- Patients for whom an home-based cardiac rehabilitation is contraindicated or not possible
Show all 19Show fewer
- Left ventricular ejection fraction (LVEF) < 40% or patients with defibrillator or cardiac resynchronisation pacemaker.
- Severe left ventricular (LV) hypertrophy (defined as septal wall thickness at echocardiography of more than > 13 mm)
- Congenital cardiac defects, severe uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mm Hg), severe anemia, suspected or known dissecting aortic aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism.
- Presence of electrocardiographic or other abnormalities/factors that could interfere with exercise electrocardiograph interpretation or may lead to a false positive stress test (See appendix B for more details)
- Clinically significant arrhythmias, rapid atrial fibrillation (> 110 beats per minute at rest) or atrioventricular conduction block greater than first degree.
- Planned need for concomitant cardiac surgery, such as valve surgery.
- Refusal or an inability to perform cardiac rehabilitation.
- Moribund patients, or patients with comorbidities limiting life expectancy < 1 year.
- Any contra-indications to the treadmill stress test (See Appendix D6)
- Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent.
- Potential for non-compliance towards the requirements in the study protocol and/or follow-up visits
- Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study.
- Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Vitality Indices Derived From the Hexoskin in Patients Affected With Angina Undergoing Coronary Revascularization or Medical Therapy (NOVA-SKIN Study)
The first and foremost manifestation of ischemic heart disease (IHD) is angina. At a global level, patients with chronic angina are at risk of poor vital status and deconditioning. Medical therapy and coronary revascularization using coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) can effectively relieve angina . In spite of all the available treatment options, the assessment of angina remains a challenge. Angina has a cyclical pattern and will naturally worsen and improve as days go by. Likewise, angina can be significantly biased by the placebo effect. Clinically angina is most frequently quantified with the Canadian Cardiovascular Society (CCS) classes system. In research protocols, angina is often quantified with health-related quality of life questionnaires and diaries. None of the tool available accounts for an important phenomenon called ischemic threshold adaptation, which could be defined as a limitation of their activity level under the ischemic level, which will translate into fewer angina episodes and a seemingly stable condition. Better clinical assessment tools that take into consideration the ischemic threshold adaption are needed.
Despite increased interest in wearable biometrics clothing in medicine, no prospective study has documented their utility to assess angina and to monitor the rehabilitation in cardiac patients. The Hexoskin™ is a biometric vest that can collect physiological data from individuals in their natural daily living environment. Currently, the use of biometric clothing is confined to a niche exploited exclusively by health enthusiasts, athletes or astronauts. As we enter this new age of virtual healthcare, tools like wearable biometrics could represent a giant leap forward in assisting healthcare professionals and patients. This will translate a better assessment of their health status, will allow physicians to target the right treatment strategy, ultimately improving case-selection and outcomes.
Our objective is to prospectively validate the wearable biometrics clothing Hexoskin™ against established standards used to assess chronic stable angina. In addition, the investigators want to derive a novel vitality index from the data generated by this device that will subsequently be used to propose a new angina classification system that will account for ischemic threshold adaptation. Moreover, the investigators want to evaluate the safety and efficacy of Hexoskin monitor patients undergoing home-based cardiac rehabilitation.
- Conditions
- Chronic Stable Angina
- Being tested
- Hexoskin Vest, Cardiac rehabilitation program, Anxiety assessment as determined by the GAD-7, Angina assessment with the angina diary, the SAQ and the SF-36, Exercise stress test
- Keywords
- Hexo-Skin, Hexoskin, NOVA-SKIN, angina, biometric vest
- Medical subject headings
- Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexoskin VestDevice
The Hexoskin vest will be used at home to monitor the patient before and after the coronary angiography, during a treadmill test and during a home cardiac rehabilitation program.
Cardiac rehabilitation programBehavioural
A 6 sessions home cardiac rehabilitation program will be prescribed to the patient 2 to 4 weeks after the coronary angiogram. Those sessions will take place under Hexoskin surveillance. One session will take place at our specialized institution and six sessions will take place at home over the time span of two to three weeks.
Anxiety assessment as determined by the GAD-7Other
Anxiety assessment using the General Anxiety Disorder (GAD-7) scale, at the end of the study, to see if the Hexoskin relieved the anxiety patients can feel at home when exercising after a percutaneous coronary intervention.
Angina assessment with the angina diary, the SAQ and the SF-36Other
Also called Angina assessment with the angina diary, the Seattle Angina Questionnaire (SAQ) and the Short Form 36 (SF-36)
Exercise stress testOther
Using the RAMP protocol before and after the coronary intervention, under Hexoskin surveillance.
Holter monitoringOther
24-hour Holter monitoring before and after the coronary angiogram with simultaneous Hexoskin reading.
| Study group | Role | What they receive |
|---|---|---|
| Stable Angina with coronary angiogram | This study aims to correlate the biometric data collected and derived from the Hexoskin with the standard physiological assessment, in patients referred for coronary angiography for limiting angina. Afterwards, the clinician will decide of the best treatment strategy for the patient: coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) or no revascularization. Receives: Device: Hexoskin Vest; Behavioral: Cardiac rehabilitation program; Other: Anxiety assessment as determined by the GAD-7; Other: Angina assessment with the angina diary, the SAQ and the SF-36; Other: Exercise stress test; Other: Holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Hexoskin measures : Average heart rate
Correlation between the heart rate as determined by the Hexoskin with the reference data provided by the Holter monitoring and treadmill stress test
Measured: Two months to three months
Validation of the vitality index with angina class as assessed by the CCS Class
Measured: Two to three months
Validation of the vitality index with quality of life using the Seattle Angina Questionnaire
The changes in the vitality index compared with changes quality-of-life as measured by the Seattle Angina Questionnaire
Measured: Two to three months
Validation of the vitality index with Anxiety using the GAD-7
The changes in the vitality index compared with changes of anxiety as measured by the General Anxiety Disorder Scale - 7 .
Measured: Two to three months
Validation of the vitality index with quality of life using the SF-36
The changes in the vitality index compared with changes quality-of-life as measured by the Short-Form 36 (SF-36).
Measured: Two to three months
Validation of the vitality index with Anxiety using the ASI-3
The changes in the vitality index compared with changes of anxiety as measured by the Anxiety Sensitivity Index (ASI-3)
Measured: Two to three months
Responsiveness to the revascularisation procedure or medical treatment
Difference of the vitality index before and after the revascularisation procedure or medical treatment
Measured: Two to three months
Validation of the Hexoskin measures : Arrhythmia detection
: Correlation between the arrhythmias as determined by the Hexoskin with the reference data provided by the Holter monitoring.
Measured: Two to three months
Adjusting of the different subdomains of SF-36, Seattle Angina Questionnaire, Treadmill length, CCS class and weekly angina count before and after the coronary angiogram for the vitality index
Adjusting of the different subdomains of SF-36, Seattle Angina Questionnaire, Treadmill length, CCS class and weekly angina count before and after the coronary angiogram for the vitality index and comparison between the difference detected before \& after compared to the unadjusted metrics
Measured: Two to three months
Secondary outcomes (5)
Major adverse cardiac events (MACE)
Mortality, re-infarction, revascularization procedure, ventricular arrhythmias and re-hospitalisation for angina.
Measured: Two to three months
Safety outcomes of the Hexoskin (Allergies, Intolerance)
Allergies, Intolerance
Measured: Two to three months
Resource utilisation : Any overnight hospital stay
- Rehospitalisation: Any overnight stay at the hospital.
- Coronary care unit admission: Any overnight stay at the coronary care unit.
- Intensive care unit admission: Any overnight stay at the intensive care unit.
Measured: Two to three months
Medical contact (Number of phone calls or unplanned clinic or emergency visit to the physician per patient)
Any phone call or unplanned clinic visit to a physician.
Measured: Two to three months
Remote signal transmission integrity
- Defined as the number of seconds the Hexoskin does not transmit any interpretable data divided by the total time the Hexoskin has been worn.
Measured: Two to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Jolicoeur, Montreal Heart Institute
- Investigators
- Marc Jolicoeur Jolicoeur, MD, M.Sc., MHS, Study chair, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591758
- Sponsor's protocol ID
- 2015-1919
- Acronym
- NOVA-SKIN
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2015
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Vitality Indices Derived From the Hexoskin in Patients Affected With Angina Undergoing Coronary Revascularization or Medical Therapy (NOVA-SKIN Study)
- ClinicalTrials.gov ID
- NCT02591758
- Acronym / sponsor ID
- NOVA-SKIN / 2015-1919
- Conditions
- Chronic Stable Angina
- Keywords
- Hexo-Skin, Hexoskin, NOVA-SKIN, angina, biometric vest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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 first and foremost manifestation of ischemic heart disease (IHD) is angina. At a global level, patients with chronic angina are at risk of poor vital status and deconditioning. Medical therapy and coronary revascularization using coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) can effectively relieve angina . In spite of all the available treatment options, the assessment of angina remains a challenge. Angina has a cyclical pattern and will naturally worsen and improve as days go by. Likewise, angina can be significantly biased by the placebo effect. Clinically angina is most frequently quantified with the Canadian Cardiovascular Society (CCS) classes system. In research protocols, angina is often quantified with health-related quality of life questionnaires and diaries. None of the tool available accounts for an important phenomenon called ischemic threshold adaptation, which could be defined as a limitation of their activity level under the ischemic level, which will translate into fewer angina episodes and a seemingly stable condition. Better clinical assessment tools that take into consideration the ischemic threshold adaption are needed.
Despite increased interest in wearable biometrics clothing in medicine, no prospective study has documented their utility to assess angina and to monitor the rehabilitation in cardiac patients. The Hexoskin™ is a biometric vest that can collect physiological data from individuals in their natural daily living environment. Currently, the use of biometric clothing is confined to a niche exploited exclusively by health enthusiasts, athletes or astronauts. As we enter this new age of virtual healthcare, tools like wearable biometrics could represent a giant leap forward in assisting healthcare professionals and patients. This will translate a better assessment of their health status, will allow physicians to target the right treatment strategy, ultimately improving case-selection and outcomes.
Our objective is to prospectively validate the wearable biometrics clothing Hexoskin™ against established standards used to assess chronic stable angina. In addition, the investigators want to derive a novel vitality index from the data generated by this device that will subsequently be used to propose a new angina classification system that will account for ischemic threshold adaptation. Moreover, the investigators want to evaluate the safety and efficacy of Hexoskin monitor patients undergoing home-based cardiac rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable Angina with coronary angiogram | – | Device: Hexoskin Vest, Behavioral: Cardiac rehabilitation program, Other: Anxiety assessment as determined by the GAD-7, Other: Angina assessment with the angina diary, the SAQ and the SF-36, Other: Exercise stress test, Other: Holter monitoringThis study aims to correlate the biometric data collected and derived from the Hexoskin with the standard physiological assessment, in patients referred for coronary angiography for limiting angina. Afterwards, the clinician will decide of the best treatment strategy for the patient: coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) or no revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty (30) subjects who meet all of the inclusion criteria and none of the exclusion criteria and who successfully wear the Hexoskin vest in the run-in will be eligible to study participation. Subjects will be recruited as outpatient, from the specialized angina clinic at the Montreal Heart Institute (MHI) or as an inpatient, after screening by the research team.
Key inclusion criteria (8 listed)
- Written informed consent form
- Patient 18 years of age
- History of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) of myocardial infarction or significant coronary artery disease with non-invasive angiographic confirmation.
- Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes.
- All-comers with stable or unstable moderate-to-severe angina pectoris (Canadian Cardiovascular Class [CCS] II-III or IV subsequently medically stabilized (minimum 7 days) despite guideline directed medical therapy due to a reversible myocardial ischemia deemed sufficiently severe to justify a coronary angiography.
Key exclusion criteria (19 listed)
- Recent (<1 week) acute coronary syndrome
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the 3 months prior to screening.
- Severe valvular disease
- High-risk criteria demonstrated on the treadmill stress test (Appendix D5)
- With contraindications to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform treadmill stress test (including but not limited to : pulmonary hypertension, functionally limiting chronic obstructive pulmonary disease (COPD), history of pulmonary tuberculosis, prior hospitalization for acute exacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapy that can limit exercise capacity, functionally limiting peripheral artery disease.
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 |
|---|---|---|
| Hexoskin VestThe Hexoskin vest will be used at home to monitor the patient before and after the coronary angiography, during a treadmill test and during a home cardiac rehabilitation program. | Device | Stable Angina with coronary angiogram |
| Cardiac rehabilitation programA 6 sessions home cardiac rehabilitation program will be prescribed to the patient 2 to 4 weeks after the coronary angiogram. Those sessions will take place under Hexoskin surveillance. One session will take place at our specialized institution and six sessions will take place at home over the time span of two to three weeks. | Behavioural | Stable Angina with coronary angiogram |
| Anxiety assessment as determined by the GAD-7Anxiety assessment using the General Anxiety Disorder (GAD-7) scale, at the end of the study, to see if the Hexoskin relieved the anxiety patients can feel at home when exercising after a percutaneous coronary intervention. | Other | Stable Angina with coronary angiogram |
| Angina assessment with the angina diary, the SAQ and the SF-36Also: Angina assessment with the angina diary, the Seattle Angina Questionnaire (SAQ) and the Short Form 36 (SF-36) | Other | Stable Angina with coronary angiogram |
| Exercise stress testUsing the RAMP protocol before and after the coronary intervention, under Hexoskin surveillance. | Other | Stable Angina with coronary angiogram |
| Holter monitoring24-hour Holter monitoring before and after the coronary angiogram with simultaneous Hexoskin reading. | Other | Stable Angina with coronary angiogram |
Primary outcome
Validation of the Hexoskin measures : Average heart rate
Time frame: Two months to three months
Correlation between the heart rate as determined by the Hexoskin with the reference data provided by the Holter monitoring and treadmill stress test
Validation of the vitality index with angina class as assessed by the CCS Class
Time frame: Two to three months
Validation of the vitality index with quality of life using the Seattle Angina Questionnaire
Time frame: Two to three months
The changes in the vitality index compared with changes quality-of-life as measured by the Seattle Angina Questionnaire
Validation of the vitality index with Anxiety using the GAD-7
Time frame: Two to three months
The changes in the vitality index compared with changes of anxiety as measured by the General Anxiety Disorder Scale - 7 .
Validation of the vitality index with quality of life using the SF-36
Time frame: Two to three months
The changes in the vitality index compared with changes quality-of-life as measured by the Short-Form 36 (SF-36).
Validation of the vitality index with Anxiety using the ASI-3
Time frame: Two to three months
The changes in the vitality index compared with changes of anxiety as measured by the Anxiety Sensitivity Index (ASI-3)
Responsiveness to the revascularisation procedure or medical treatment
Time frame: Two to three months
Difference of the vitality index before and after the revascularisation procedure or medical treatment
Validation of the Hexoskin measures : Arrhythmia detection
Time frame: Two to three months
: Correlation between the arrhythmias as determined by the Hexoskin with the reference data provided by the Holter monitoring.
Adjusting of the different subdomains of SF-36, Seattle Angina Questionnaire, Treadmill length, CCS class and weekly angina count before and after the coronary angiogram for the vitality index
Time frame: Two to three months
Adjusting of the different subdomains of SF-36, Seattle Angina Questionnaire, Treadmill length, CCS class and weekly angina count before and after the coronary angiogram for the vitality index and comparison between the difference detected before \& after compared to the unadjusted metrics
5 secondary outcomes
Major adverse cardiac events (MACE)
Time frame: Two to three months
Safety outcomes of the Hexoskin (Allergies, Intolerance)
Time frame: Two to three months
Resource utilisation : Any overnight hospital stay
Time frame: Two to three months
Medical contact (Number of phone calls or unplanned clinic or emergency visit to the physician per patient)
Time frame: Two to three months
Remote signal transmission integrity
Time frame: Two to three months
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 5 Oct 2018.
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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.
Marc Jolicoeur Jolicoeur, MD, M.Sc., MHS study chair
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stable Angina, run by Montreal Heart Institute at 1 site in Canada.
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 8 inclusion and 19 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 5 Oct 2018. 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 Canada. 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?
Validation of the Hexoskin measures : Average heart rate (time frame: Two months to three months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2018.