Individual Study / Birkeland et al.; JMIR Res Protoc. 2017

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

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

Population

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