Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery (TEBCABG)
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| First Received Date ICMJE | January 23, 2013 | ||||||||
| Last Updated Date | January 29, 2013 | ||||||||
| Start Date ICMJE | March 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Blood flow redistribution - baseline and 5 days later [ Time Frame: 1 day ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE |
Blood flow redistribution [ Time Frame: 5 day ] [ Designated as safety issue: Yes ] The ultrasound Doppler system will be equipped with two linear array transducers operating at an imaging frequency of 7- 8 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 (Vmean ), femoral blood flow (FBF) was calculated as Vmean 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. |
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| Change History | Complete list of historical versions of study NCT01777659 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Inspiratory and Expiratory Muscle Function [ Time Frame: 5 day ] [ Designated as safety issue: Yes ] 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. |
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| Original Secondary Outcome Measures ICMJE |
Inspiratory and Expiratory Muscle Function [ Time Frame: 5 day ] [ Designated as safety issue: Yes ] Inspiratory and expiratory muscle strength testing were performed using a pressure transducer (MVD-500 V.1.1 Microhard System, Globalmed, Porto Alegre, Brazil). Maximal inspiratory (PImax), and maximal static expiratory pressure (PEmax) were measured as previously described. |
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| Current Other Outcome Measures ICMJE |
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| Original Other Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery | ||||||||
| Official Title ICMJE | Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery | ||||||||
| Brief 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). |
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| 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). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Acute Myocardial Infarction | ||||||||
| Intervention ICMJE | Device: Transcutaneous electrical nerve 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.
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 48 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
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| Location Countries ICMJE | Brazil | ||||||||
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| NCT Number ICMJE | NCT01777659 | ||||||||
| Other Study ID Numbers ICMJE | 12-0317 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator, Hospital de Clinicas de Porto Alegre | ||||||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||||||
| Collaborators ICMJE | University of Brasilia | ||||||||
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| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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