An observational study in Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty and Coronary Artery Bypass, sponsored by ROM Technologies, INC. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by ROM Technologies, INC · Observational
The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.
The focus of this study is to determine the feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. The study consists of an initial review, rehabilitation sessions, nutrition consultation, and risk stratification. Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device exercises.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 500 is below the median of 568 across 814 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →ROM Technologies, INC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.
Device: ROMTech Portable Connect
The ROMTech PortableConnect Rehab System is a continuous rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion.
Also known as: ROMTech PC, ROMTech PortableConnect Rehab System
Session attended
Measure the number of sessions attended to determine the ease of patients to utilize home-based cardiac rehab integrated with telemedicine (non-inferiority to historical controls)
Time frame: 12 weeks (End of treatment)
Sessions completed
Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine
Time frame: 12 weeks(End of treatment)
Duke Activity Status Index (DASI)
Estimate of functional capacity
Time frame: Baseline, 12 weeks (End of Treatment)
Patient Health Questionnaire(PHQ)
Quality of Life assessment
Time frame: Baseline, 12 weeks (End of Treatment)
Short Physical Performance Battery
Lower extremity functional assessment
Time frame: Baseline, 12 weeks (End of Treatment)
Short Form-36
Quality of Life assessment
Time frame: Baseline, 12 weeks (End of Treatment)
Laboratory assessment
To determine if there is an improvement in low density lipoprotein, triglycerides,
Time frame: Baseline, 12 weeks (End of Treatment)
Started Jun 2023 (actual). Primary completion is estimated for Oct 2025, 28 months after the start.
Of 37 industry-sponsored observational studies under Myocardial Infarction, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's planned 28 months is above that.
Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ROM Technologies, INC