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

Chronic Stable Angina Clinical Trial

— NOVA-SKIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591758
• Other study ID #: 2015-1919
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: July 17, 2018

Study information

• Verified date: October 2018
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent form

2. Patient 18 years of age

3. 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.

4. 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.

5. 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.

6. Patient can be treated percutaneously, surgically or medically.

7. Willing to undertake a cardiac rehabilitation program at home

8. 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.

Exclusion Criteria:

1. Recent (<1 week) acute coronary syndrome

2. Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the 3 months prior to screening.

3. Severe valvular disease

4. High-risk criteria demonstrated on the treadmill stress test (Appendix D5)

5. 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.

6. Patients for whom an home-based cardiac rehabilitation is contraindicated or not possible

7. Left ventricular ejection fraction (LVEF) < 40% or patients with defibrillator or cardiac resynchronisation pacemaker.

8. Severe left ventricular (LV) hypertrophy (defined as septal wall thickness at echocardiography of more than > 13 mm)

9. 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.

10. 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)

11. Clinically significant arrhythmias, rapid atrial fibrillation (> 110 beats per minute at rest) or atrioventricular conduction block greater than first degree.

12. Planned need for concomitant cardiac surgery, such as valve surgery.

13. Refusal or an inability to perform cardiac rehabilitation.

14. Moribund patients, or patients with comorbidities limiting life expectancy < 1 year.

15. Any contra-indications to the treadmill stress test (See Appendix D6)

16. 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.

17. Potential for non-compliance towards the requirements in the study protocol and/or follow-up visits

18. 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.

19. 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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina

Intervention

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.
• Angina assessment with the angina diary, the SAQ and the SF-36

• Exercise stress test
Using the RAMP protocol before and after the coronary intervention, under Hexoskin surveillance.
• Holter monitoring
24-hour Holter monitoring before and after the coronary angiogram with simultaneous Hexoskin reading.

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Validation of the vitality index with angina class as assessed by the CCS Class		Two to three months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Responsiveness to the revascularisation procedure or medical treatment	Difference of the vitality index before and after the revascularisation procedure or medical treatment	Two to three months
Primary	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
Primary	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
Secondary	Major adverse cardiac events (MACE)	Mortality, re-infarction, revascularization procedure, ventricular arrhythmias and re-hospitalisation for angina.	Two to three months
Secondary	Safety outcomes of the Hexoskin (Allergies, Intolerance)	Allergies, Intolerance	Two to three months
Secondary	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.	Two to three months
Secondary	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
Secondary	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