NCT02591758: NOVA-SKIN

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

Completed Last updated 5 October 2018

What this trial tests

trial testing Hexoskin Vest in Chronic Stable Angina in 30 participants. Completed in 17 July 2018.

Timeline

1 October 2015

Primary endpoint
17 July 2018

17 July 2018

Quick facts

Lead sponsor	Montreal Heart Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 October 2015
Primary completion	17 July 2018
Estimated completion	17 July 2018
Sites	1 location across Canada

Drugs / interventions 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
• Holter monitoring

Conditions studied

• Chronic Stable Angina — all drugs for Chronic Stable Angina →

Sponsor

Montreal Heart Institute

Who can join

18 and older, any sex, with Chronic Stable Angina. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review.
   Marquis-Gravel G, Moliterno DJ, Francis DP, Jüni P, et al · · 2020 · cited 8× · PMID 32703515 · DOI 10.1016/j.jacc.2020.05.060