NCT02591758

Novel Vitality Indices Derived From the Hexoskin in Patients Affected With Angina Undergoing Coronary Revascularization or Medical Therapy

Novel Vitality Indices Derived From the Hexoskin in Patients Affected With Angina Undergoing Coronary Revascularization or Medical Therapy (NOVA-SKIN Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DEVICE	Hexoskin Vest	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.
BEHAVIORAL	Cardiac rehabilitation program	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.
OTHER	Anxiety assessment as determined by the GAD-7	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.
OTHER	Angina assessment with the angina diary, the SAQ and the SF-36
OTHER	Exercise stress test	Using the RAMP protocol before and after the coronary intervention, under Hexoskin surveillance.
OTHER	Holter monitoring	24-hour Holter monitoring before and after the coronary angiogram with simultaneous Hexoskin reading.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2015-10-30
• Last updated: 2018-10-05

Locations

1 site across 1 country: Canada