Cardiovascular DiseasesNCT04812600
Microfluidic-based Tactile Sensor in Cardiac Rehabilitation
An observational study of Cardiovascular Diseases and Vascular Stiffness, run by Zhili hao at 1 site in United States.
Trial summary
This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Vascular Stiffness, Endothelial Dysfunction
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2021to 20 Mar 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who are undergoing Phase II (outpatient) cardiac rehabilitation at Sentara Heart Hospital (Norfolk, Va) and meet the inclusion and exclusion criteria listed will be recruited for the study.
Who may be able to join
- Age 45-70
- Subjects who qualify for cardiac rehabilitation via doctor's orders
Who cannot join
- ●Physical limitations which would preclude one from performing exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sentara Heart Hospital
Norfolk, Virginia, 23501
Jennifer May, Ph.D., 757-388-1926, jlfreema@sentara.com
About this study
Official title: Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation
This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after exercise (1, 3, 5, 10, 30 and 60 mins). The investigators will study these responses at the first session of cardiac rehabilitation and following 1 and 4 weeks of cardiac rehabilitation (sessions 3 and 6). The investigators will also collect some information from the medical record regarding: age, gender, body mass index, resting cardiovascular measures (heart rate, blood pressure etc), medications, reasons which qualified the participant into cardiac rehabilitation, blood tests related to heart or cardiovascular function, metabolic panel, lipid panel, echocardiogram results, recorded electrocardiogram, known vascular diseases, presence of implantable devices, Seattle Heart Failure Model data and cardiovascular measures and exercise workloads during cardiac rehabilitation.
Read the detailed description
The investigators will make the following research measurements (pre-exercise measurement and post-exercise measurement) on the first day of cardiac rehab, and following 1 and 4 weeks of cardiac rehabilitation.
Subjects will have their arterial pulse measured at the radial (wrist), carotid (neck) and temple (side of the head) arteries. The sensor will remain in place for 2-3 minutes while the recordings are made. Light pressure will be applied during this time. Blood pressure will also be obtained in the opposite arm.
The subject will then exercise on the modalities, intensity and duration designated by the staff in the Sentara Heart Hospital Cardiac Rehabilitation. It's important to note, that the normal standard of care will not change by the individual participating in this research study. The participants will follow standard physician ordered cardiac rehabilitation. The order of the modalities performed will be completed in the same order on the day of research testing in weeks 1 and 4.
After finishing the exercise, the subject will sit down for 1hr. The participant's pulse signals will be measured at 0-5min, 10min, 20 min, 30min and 1hr after exercise. Blood pressure will also be obtained from the opposite arm at the same time intervals.
The investigators will be collecting cardiac rehab data from each research day. This data will be entered into Redcap by the Sentara researchers.
The investigators will record from the most recent values/visits prior to start of cardiac rehab therapy, and this information will be entered into Redcap by the Sentara researchers.
The investigators will document at 1, 2 and 3 years from start of cardiac rehab, as to patient survival status.
- Keywords
- Exercise, vascular disease, cardiac rehabilitation
- Medical subject headings
- Cardiovascular Diseases, Motor Activity, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | Individuals assigned to phase II (outpatient) cardiac rehabilitation program will undergo their normal exercise routines while the investigators make the measurements pre and post exercise at 0 week, and following 1 and 4 weeks of exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-tactile sensor assessment of arterial stiffness change to exercise
Elasticity (unit measure: pascal) of arterial wall will be assessed.
Measured: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Micro-tactile sensor assessment of arterial viscosity change to exercise
Damping (unit measure: pascal x sec) of the arterial wall will be assessed.
Measured: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Micro-tactile sensor assessment of arterial radius change to exercise
Size of the artery lumen (unit measure: mm) will be assessed.
Measured: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise
Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.
Measured: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start20 Mar 2021 (estimated)
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 30 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhili hao
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Virginia Medical School
- Responsible party
- Sponsor-investigator, Zhili hao, Old Dominion University
- Investigators
- Julie Hao, Ph.D., Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812600
- Sponsor's protocol ID
- 19-04-FB-0100
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT04812600
- Acronym / sponsor ID
- 19-04-FB-0100
- Keywords
- Exercise, vascular disease, cardiac rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhili haoUniversity, hospital or other
- Collaborators
- Eastern Virginia Medical School
- Study start
- 20 Mar 2021 (estimated)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 23 Mar 2021 (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.
This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after exercise (1, 3, 5, 10, 30 and 60 mins). The investigators will study these responses at the first session of cardiac rehabilitation and following 1 and 4 weeks of cardiac rehabilitation (sessions 3 and 6). The investigators will also collect some information from the medical record regarding: age, gender, body mass index, resting cardiovascular measures (heart rate, blood pressure etc), medications, reasons which qualified the participant into cardiac rehabilitation, blood tests related to heart or cardiovascular function, metabolic panel, lipid panel, echocardiogram results, recorded electrocardiogram, known vascular diseases, presence of implantable devices, Seattle Heart Failure Model data and cardiovascular measures and exercise workloads during cardiac rehabilitation.
Detailed description
The investigators will make the following research measurements (pre-exercise measurement and post-exercise measurement) on the first day of cardiac rehab, and following 1 and 4 weeks of cardiac rehabilitation.
Subjects will have their arterial pulse measured at the radial (wrist), carotid (neck) and temple (side of the head) arteries. The sensor will remain in place for 2-3 minutes while the recordings are made. Light pressure will be applied during this time. Blood pressure will also be obtained in the opposite arm.
The subject will then exercise on the modalities, intensity and duration designated by the staff in the Sentara Heart Hospital Cardiac Rehabilitation. It's important to note, that the normal standard of care will not change by the individual participating in this research study. The participants will follow standard physician ordered cardiac rehabilitation. The order of the modalities performed will be completed in the same order on the day of research testing in weeks 1 and 4.
After finishing the exercise, the subject will sit down for 1hr. The participant's pulse signals will be measured at 0-5min, 10min, 20 min, 30min and 1hr after exercise. Blood pressure will also be obtained from the opposite arm at the same time intervals.
The investigators will be collecting cardiac rehab data from each research day. This data will be entered into Redcap by the Sentara researchers.
The investigators will record from the most recent values/visits prior to start of cardiac rehab therapy, and this information will be entered into Redcap by the Sentara researchers.
The investigators will document at 1, 2 and 3 years from start of cardiac rehab, as to patient survival status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | – | –Individuals assigned to phase II (outpatient) cardiac rehabilitation program will undergo their normal exercise routines while the investigators make the measurements pre and post exercise at 0 week, and following 1 and 4 weeks of exercise. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are undergoing Phase II (outpatient) cardiac rehabilitation at Sentara Heart Hospital (Norfolk, Va) and meet the inclusion and exclusion criteria listed will be recruited for the study.
Key inclusion criteria (2 listed)
- Age 45-70
- Subjects who qualify for cardiac rehabilitation via doctor's orders
Key exclusion criteria (1 listed)
- ●Physical limitations which would preclude one from performing exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Micro-tactile sensor assessment of arterial stiffness change to exercise
Time frame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Elasticity (unit measure: pascal) of arterial wall will be assessed.
Micro-tactile sensor assessment of arterial viscosity change to exercise
Time frame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Damping (unit measure: pascal x sec) of the arterial wall will be assessed.
Micro-tactile sensor assessment of arterial radius change to exercise
Time frame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Size of the artery lumen (unit measure: mm) will be assessed.
Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise
Time frame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Julie Hao, Ph.D. principal investigator
Old Dominion University
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 Cardiovascular Diseases and Vascular Stiffness, run by Zhili hao 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Hao, Ph.D. (757-683-6734, zlhao@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micro-tactile sensor assessment of arterial stiffness change to exercise (time frame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation). The study lists 4 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 23 Mar 2021.