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Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting

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ClinicalTrials.gov Identifier: NCT03525860
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Chaim Leker Locker, Mayo Clinic

Brief Summary:
A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients who have undergone open heart surgery procedures. The acupuncture treatments may begin as early as postoperative Day 2.

Condition or disease Intervention/treatment Phase
Post-Operative Atrial Fibrillation Acupuncture Therapy Procedure: Acupuncture Not Applicable

Detailed Description:

Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias.

Secondary Aims

• Evaluate the short-term effect of acupuncture including the effects on patient's arrhythmias, stress, anxiety, and pain measured by Electrocardiogram monitoring and Electrocardiography, VAS scores, and WIWI questionnaire for the patient.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility of Acupuncture Treatment in the Post-Operative Cardio-Thoracic Setting for Arrhythmias in Patients Undergoing Open Heart Surgery- A Pilot Study
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture Treatment

20 subjects will be treated with standard of care and acupuncture.

Will complete Symptom and Pain questionnaire (VAS) and a Was It Worth It (WIWI) questionnaire each day of study participation (3 days).

Procedure: Acupuncture

The subject is placed in the selected position (lying down or sitting), based on their comfort level. The areas to be needled are prepped with an alcohol swab. Mandatory standards and safety guidelines for acupuncture will be followed.

The acupuncture treatment protocol will be based on Traditional Chinese Medicine (TCM) theory. The TCM treatment strategy is designed to Benefit the Heart, Tonify Heart Qi and Blood, Calm and Sedate Cardiac Excitability and Regulate the Qi. Current literature supports the use of selected acupuncture points as possibly beneficial in regulating the autonomic nervous system, modulating Heart Rate Variability (HRV), relieving chest pain, and reducing arrhythmias.

11 sterile, single use, disposable needles will be placed one by one until all needles are in place.

Needles remain in place for additional 20 minutes or so as the patient remains in the selected position


No Intervention: No Intervention

20 subjects will be treated with standard of care only.

Will complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).




Primary Outcome Measures :
  1. Acupuncture treatment in the hospital setting [ Time Frame: 3 days post surgery ]
    The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.


Secondary Outcome Measures :
  1. Number of patients with recurrent atrial fibrillation [ Time Frame: 3 consecutive days post-surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have undergone CABG and/or cardiac valve operations.
  2. Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.
  3. Patients moving to the step-down unit on postoperative day 2 or later.
  4. Ability to provide informed consent.
  5. Ability to speak English and complete all aspects of this trial.
  6. At least 18 years of age.

Exclusion Criteria:

  1. Patients with any other cardiac or non-cardiac concomitant procedures.
  2. Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.
  3. Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.
  4. Patients with platelet count <50,000
  5. Patients in a severe immunocompromised state.
  6. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525860


Contacts
Contact: Heather Ondler Hinson, CRC 507-284-4799 ondlerhinson.heather@mayo.edu
Contact: Molly Mallory, L.Ac. 507-538-4217 mallory.molly@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Chaim Leker Locker, M.D. Mayo Clinic

Responsible Party: Chaim Leker Locker, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03525860     History of Changes
Other Study ID Numbers: 17-006095
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes