Acute Myocardial InfarctionTEBCABGNCT01777659
Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery
A study testing Transcutaneous electrical nerve stimulation in people with Acute Myocardial Infarction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The investigators will test the hypothesis that transcutaneous electrical nerve stimulation (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary Arterial Bypass Graft Surgery (CABG). Read more about this study
- Who is it for?
- Ages 48 to 70 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Oct 2013
- Phase
- Interventional
- 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 48 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a previous history of more than 1 vessel coronary artery disease,
- lifelong abstinence from tobacco, and
- formal indication for CABG, according to established guideline.
Who cannot join
- Patients older than 70 years of age, with chronic renal failure, or with unstable angina in the 48 h prior to CABG, moderate or severe valve disease, complex cardiac arrhythmias, stroke, and/or inability to exercise the lower limbs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
About this study
The investigators will test the hypothesis that transcutaneous electrical nerve stimulation (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary Arterial Bypass Graft Surgery (CABG).
Read the detailed description
Thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program of TENS (n = 20) or to placebo-TENS (P-TENS, n = 18) applied on cervical region (C7-T4). Acute sympathetic stimulation by cold pressor test (CPT), Maximal voluntary contraction (MVC), Femoral blood flow (FBF) and femoral vascular conductance (FVC) will be measured as primary outcome pre and post-CABG, even as the 6-minute walk test (6-MWT), Inspiratory and expiratory muscle strength (PImax and PEmax) and β-endorphin as a secondary clinical parameters. In addition, amount of opioid analgesic and pain intensity also will be measured throughout at first 24 hours after CABG (immediately, 6, 12 and 24 hours).
- Conditions
- Acute Myocardial Infarction
- Being tested
- Transcutaneous electrical nerve stimulation
- Keywords
- exercise, neuromodulation, blood flow, exercise capacity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Also called TENS, electrical stimulation
Patients will be treated with conventional TENS (ENDOMED 684 Device, ENRAF-Nonius B.V., Rotterdam, Netherlands) for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). TENS intervention was applied as described elsewhere.
| Study group | Role | What they receive |
|---|---|---|
| TENS CABG | Experimental | Eligible patients will be randomized to a transcutaneous electrical nerve stimulation program (TENS; n = 20) or to placebo-TENS (P-TENS; n = 18). All patients were followed by their own physicians, received routine nursing assistance, and were visited daily by one of the investigators, but P-TENS group will be not exposed to any specific electrical stimulation or motor physical intervention. Receives: Device: Transcutaneous electrical nerve stimulation |
| P-TENS CABG | Placebo comparator | Patients will be treated with placebo-TENS (P-TENS) condition for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). P-TENS device underwent modifications in its internal programming: the control capacitor of the time constant was changed and the active time between pulses was modified from 330 milliseconds to 33 seconds, in order to prevent an analgesic effect (33). Receives: Device: Transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow redistribution - baseline and 5 days later
The ultrasound Doppler system will be equipped with two linear array transducers operating at an imaging frequency of 7- 8 megahertz (MHz). The common femoral artery of the left leg will be insonated distal to the inguinal ligament, 2-3 cm proximal to the bifurcation. Using femoral artery diameter and mean blood velocity (MBF), femoral blood flow (FBF) was calculated as MBF π x (vessel diameter/2)2 x 60. Femoral vascular resistance (FVR) and femoral vascular conductance (FVC) were calculated as (MBP/FBF) and (FBF/MBP * 100 mm Hg), the conductance multiplied by 100 mmHg so that the conductance units will be similar to the units of femoral blood flow (10, 45). The magnitude of reduction FVC (expressed in %) was calculated as vascular conductance during exercise (% change) - conductance at rest (% change) expressed by % of baseline.
Measured: 1 day
Secondary outcomes (1)
Inspiratory and Expiratory Muscle Function
Inspiratory and expiratory muscle strength testing were performed using a pressure transducer (MVD-500 V.1.1 Micro Hard System, Global Med, Porto Alegre, Brazil). Maximal inspiratory (PImax), and maximal static expiratory pressure (PEmax) were measured as previously described.
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brasilia, Hospital Sao Joao
- Responsible party
- Principal investigator, GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator, Hospital de Clinicas de Porto Alegre
- Investigators
- Gaspar R Chiappa, Dr, ScD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777659
- Sponsor's protocol ID
- 12-0317
- Acronym
- TEBCABG
- Status last verified
- Nov 2013
- First submitted
- 23 Jan 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT01777659
- Acronym / sponsor ID
- TEBCABG / 12-0317
- Conditions
- Acute Myocardial Infarction
- Keywords
- exercise, neuromodulation, blood flow, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- University of Brasilia, Hospital Sao Joao
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Jan 2013 (estimated)
- 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 investigators will test the hypothesis that transcutaneous electrical nerve stimulation (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary Arterial Bypass Graft Surgery (CABG).
Detailed description
Thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program of TENS (n = 20) or to placebo-TENS (P-TENS, n = 18) applied on cervical region (C7-T4). Acute sympathetic stimulation by cold pressor test (CPT), Maximal voluntary contraction (MVC), Femoral blood flow (FBF) and femoral vascular conductance (FVC) will be measured as primary outcome pre and post-CABG, even as the 6-minute walk test (6-MWT), Inspiratory and expiratory muscle strength (PImax and PEmax) and β-endorphin as a secondary clinical parameters. In addition, amount of opioid analgesic and pain intensity also will be measured throughout at first 24 hours after CABG (immediately, 6, 12 and 24 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS CABG | Experimental | Device: Transcutaneous electrical nerve stimulationEligible patients will be randomized to a transcutaneous electrical nerve stimulation program (TENS; n = 20) or to placebo-TENS (P-TENS; n = 18). All patients were followed by their own physicians, received routine nursing assistance, and were visited daily by one of the investigators, but P-TENS group will be not exposed to any specific electrical stimulation or motor physical intervention. |
| P-TENS CABG | Placebo comparator | Device: Transcutaneous electrical nerve stimulationPatients will be treated with placebo-TENS (P-TENS) condition for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). P-TENS device underwent modifications in its internal programming: the control capacitor of the time constant was changed and the active time between pulses was modified from 330 milliseconds to 33 seconds, in order to prevent an analgesic effect (33). |
Who may qualify
- Ages
- 48 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a previous history of more than 1 vessel coronary artery disease,
- lifelong abstinence from tobacco, and
- formal indication for CABG, according to established guideline.
Key exclusion criteria (1 listed)
- Patients older than 70 years of age, with chronic renal failure, or with unstable angina in the 48 h prior to CABG, moderate or severe valve disease, complex cardiac arrhythmias, stroke, and/or inability to exercise the lower limbs.
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulationAlso: TENS, electrical stimulationPatients will be treated with conventional TENS (ENDOMED 684 Device, ENRAF-Nonius B.V., Rotterdam, Netherlands) for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). TENS intervention was applied as described elsewhere. | Device | P-TENS CABG, TENS CABG |
Primary outcome
Blood flow redistribution - baseline and 5 days later
Time frame: 1 day
The ultrasound Doppler system will be equipped with two linear array transducers operating at an imaging frequency of 7- 8 megahertz (MHz). The common femoral artery of the left leg will be insonated distal to the inguinal ligament, 2-3 cm proximal to the bifurcation. Using femoral artery diameter and mean blood velocity (MBF), femoral blood flow (FBF) was calculated as MBF π x (vessel diameter/2)2 x 60. Femoral vascular resistance (FVR) and femoral vascular conductance (FVC) were calculated as (MBP/FBF) and (FBF/MBP * 100 mm Hg), the conductance multiplied by 100 mmHg so that the conductance units will be similar to the units of femoral blood flow (10, 45). The magnitude of reduction FVC (expressed in %) was calculated as vascular conductance during exercise (% change) - conductance at rest (% change) expressed by % of baseline.
1 secondary outcome
Inspiratory and Expiratory Muscle Function
Time frame: 5 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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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.
Gaspar R Chiappa, Dr, ScD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation in people with Acute Myocardial Infarction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 8 Nov 2013. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow redistribution - baseline and 5 days later (time frame: 1 day). 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 8 Nov 2013.