Myocardial InfarctionNCT05972070
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
An observational study of Myocardial Infarction and Percutaneous Transluminal Coronary Angioplasty, run by ROM Technologies, INC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass
- What is being tested?
- ROMTech Portable Connect
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.
Who may be able to join
- Over the age of 18
- NYHA Functional Class I, II,
- Recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation)
- Candidate for traditional center-based cardiac rehabilitation
Who cannot join
- Under the age of 18
- Adults lacking capacity to consent.
- NYHA Functional Class III, IV
- Acute coronary syndrome
- Systolic heart failure (LV EF <40%)
- Status post cardiac surgery for structural heart disease or heart transplant
Show all 9Show fewer
- Percutaneous coronary angioplasty
- Adults lacking capacity to consent.
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ROMTech
Brookfield, Connecticut, 06804
LaToya T King, 203-518-4735, Latoya.King@romtech.com
John Stulak, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass, Stable Angina, Heart Failure, Valve Disease, Heart
- Being tested
- ROMTech Portable Connect
- Keywords
- Cardiac rehabilitation, Home based cardiac rehabilitation, Telemedicine and Home-Based Cardiac Rehabilitation
- Medical subject headings
- Myocardial Infarction, Angina, Stable, Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROMTech Portable ConnectDevice
Also called ROMTech PC, ROMTech PortableConnect Rehab System
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac patients | Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease. Receives: Device: ROMTech Portable Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 12 weeks(End of treatment)
Duke Activity Status Index (DASI)
Estimate of functional capacity
Measured: Baseline, 12 weeks (End of Treatment)
Patient Health Questionnaire(PHQ)
Quality of Life assessment
Measured: Baseline, 12 weeks (End of Treatment)
Short Physical Performance Battery
Lower extremity functional assessment
Measured: Baseline, 12 weeks (End of Treatment)
Short Form-36
Quality of Life assessment
Measured: Baseline, 12 weeks (End of Treatment)
Secondary outcomes (1)
Laboratory assessment
To determine if there is an improvement in low density lipoprotein, triglycerides,
Measured: Baseline, 12 weeks (End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jun 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ROM Technologies, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972070
- Sponsor's protocol ID
- ROMTherapy_HBCR_1001
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
- ClinicalTrials.gov ID
- NCT05972070
- Acronym / sponsor ID
- ROMTherapy_HBCR_1001
- Conditions
- Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass, Stable Angina, Heart Failure, Valve Disease, Heart
- Keywords
- Cardiac rehabilitation, Home based cardiac rehabilitation, Telemedicine and Home-Based Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ROM Technologies, INCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac patients | – | Device: ROMTech Portable ConnectAdult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.
Key inclusion criteria (4 listed)
- Over the age of 18
- NYHA Functional Class I, II,
- Recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation)
- Candidate for traditional center-based cardiac rehabilitation
Key exclusion criteria (9 listed)
- Under the age of 18
- Adults lacking capacity to consent.
- NYHA Functional Class III, IV
- Acute coronary syndrome
- Systolic heart failure (LV EF <40%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROMTech Portable ConnectAlso: ROMTech PC, ROMTech PortableConnect Rehab SystemThe 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. | Device | Cardiac patients |
Primary outcome
Session attended
Time frame: 12 weeks (End of treatment)
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)
Sessions completed
Time frame: 12 weeks(End of treatment)
Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine
Duke Activity Status Index (DASI)
Time frame: Baseline, 12 weeks (End of Treatment)
Estimate of functional capacity
Patient Health Questionnaire(PHQ)
Time frame: Baseline, 12 weeks (End of Treatment)
Quality of Life assessment
Short Physical Performance Battery
Time frame: Baseline, 12 weeks (End of Treatment)
Lower extremity functional assessment
Short Form-36
Time frame: Baseline, 12 weeks (End of Treatment)
Quality of Life assessment
1 secondary outcome
Laboratory assessment
Time frame: Baseline, 12 weeks (End of Treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Percutaneous Transluminal Coronary Angioplasty, run by ROM Technologies, INC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LaToya T. King (2035184735, Latoya.King@romtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session attended (time frame: 12 weeks (End of treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.