Daily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial
Initiatives
-
Because late sodium channel inhibition (ranolazine) improves stress laboratory exercise duration among angina patients, the study proposed that this benefit could be quantified and translated during daily life by measuring digital wearable device-determined step count in a clinical trial.
Note: All published information has been collected from the article referenced in the Marker Paper box
below. Therefore, there may be variations with more advanced versions of the study.
- Start Year
- 2014
- End Year
- 2016
- Funding
- UL1 RR033176/RR/NCRR NIH HHS/United States T32 HL116273/HL/NHLBI NIH HHS/United States N01 HV068161/HV/NHLBI NIH HHS/United States N01HV68162/HL/NHLBI NIH HHS/United States N01HV68163/HL/NHLBI NIH HHS/United States
Design
- Study design
- Clinical trial cohort
Marker Paper
Birkeland K, Khandwalla RM, Kedan I, et al. Daily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial. JMIR Res Protoc. 2017;6(12):e255. Published 2017 Dec 20. doi:10.2196/resprot.8057
PUBMED 29263019
Recruitment
- Sources of Recruitment
-
- Families
Number of participants
- Number of participants
- 43
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Timeline
parent trial
Patients enrolled in the parent trial had symptoms and signs of myocardial ischemia, no obstructive CAD, and CMD as measured by invasive CFR or noninvasive cardiac MRI-determined MPRI.
Selection Criteria
- Newborns
- Twins
- Countries
-
- United States of America
- Ethnic Origin
-
- Health Status
-
- angina and coronary microvascular dysfunction (CMD) with no obstructive coronary artery disease
Recruitment
- Sources of recruitment
-
- Clinical patients
Number of participants
- Number of participants
- 43
- Number of participants with biosamples
Data Collection Event
The study was conducted a substudy in a randomized, double-blinded, placebo-controlled, crossover trial of participants with angina and coronary microvascular dysfunction (CMD) with no obstructive coronary artery disease to evaluate the value of digital wearable device monitoring.
- Start Date
-
2014-02
- End Date
-
2016-06
- Data sources
-
-
Mobile data collection
- Smartwatch and wearables
-
Mobile data collection