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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 Hexoskinâ„¢ 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 Hexoskinâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexoskin Vest | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Two months to three months |
| Validation of the vitality index with angina class as assessed by the CCS Class | 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 | 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 . | 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). | 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) | Two to three months |
| Responsiveness to the revascularisation procedure or medical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | Mortality, re-infarction, revascularization procedure, ventricular arrhythmias and re-hospitalisation for angina. | Two to three months |
| Safety outcomes of the Hexoskin (Allergies, Intolerance) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Jolicoeur Jolicoeur, MD, M.Sc., MHS | Montreal Heart Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
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| Cardiac rehabilitation program | Behavioral | 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. |
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| Anxiety assessment as determined by the GAD-7 | Other | 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. |
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| Angina assessment with the angina diary, the SAQ and the SF-36 | Other |
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| Exercise stress test | Other | Using the RAMP protocol before and after the coronary intervention, under Hexoskin surveillance. |
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| Holter monitoring | Other | 24-hour Holter monitoring before and after the coronary angiogram with simultaneous Hexoskin reading. |
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Difference of the vitality index before and after the revascularisation procedure or medical treatment
| 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. | 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 | Two to three months |
Allergies, Intolerance
| Two to three months |
| Resource utilisation : Any overnight hospital stay |
| 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. | Two to three months |
| Remote signal transmission integrity | o Defined as the number of seconds the Hexoskin does not transmit any interpretable data divided by the total time the Hexoskin has been worn. | Two to three months |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
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