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Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients (D-RIC-RAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Li Zhao MD,PhD, Navy General Hospital, Beijing.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02499250
First Posted: July 16, 2015
Last Update Posted: July 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Li Zhao MD,PhD, Navy General Hospital, Beijing
  Purpose
The purpose is to test whether daily ischemic conditioning of the arms over 30 days could reduce the frequency and severity of angina pectoris and improve the life quality of refractory angina pectoris patients.

Condition Intervention
Refractory Angina Pectoris Device: remote ischemic conditioning (TDFT-12-A2) Drug: Optimal medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism

Resource links provided by NLM:


Further study details as provided by Li Zhao MD,PhD, Navy General Hospital, Beijing:

Primary Outcome Measures:
  • Frequencies of angina pectoris onset [ Time Frame: 30 days ]
    The total times of angina pectoris onset over one week

  • Canadian Cardiovascular Society Angina Class [ Time Frame: 30 days ]
    Ranging from class 1 to class 4 according to its definition


Secondary Outcome Measures:
  • Flow mediated vasodilation in percentage increase [ Time Frame: 30 days ]
    Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.

  • Flow mediated vasodilation in absolute increase [ Time Frame: 30 days ]
    Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.

  • Self-Rating Anxiety Scale [ Time Frame: 30 days ]
    Reported as the Self-Rating Anxiety score

  • Self-Rating Depression Scale [ Time Frame: 30 days ]
    Reported as the Self-Rating Depression score

  • Inflammatory cytokines expression [ Time Frame: 30 days ]
    Reported as the serum levels of inflammatory cytokines measured by ELISA kits, including tumor necrosis factor(TNF-α),Interleukine(IL)-6,and IL-10; The expression of signaling proteins in separated blood mononuclear cells,including hypoxia inducible factor(HIF) 1α.

  • Grip strength [ Time Frame: 30 days ]
    Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.

  • Skin and muscle abnormalities [ Time Frame: 1,7 and 30 days ]
    Whether or not the skin of the arm has bruises, and whether or not the arm has sore or pain feeling.

  • Circulating CD34+ progenitor cells [ Time Frame: 30 days ]
    The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.


Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIPC arm
The subjects will be interviewed and have their baseline frequency and severity of angina pectoris recorded, then they will receive daily remote ischemic conditioning plus optimal medical treatment over 30 days.
Device: remote ischemic conditioning (TDFT-12-A2)
The subjects will receive twice daily of 4×5min/5min ischemic/reperfusion of both arms (remote ischemic conditioning) over 30 days using the "TDFT-12-A2" device produced by "Shenzhen TDF Tai Smart technology Co., Ltd."
Other Name: RIC
Drug: Optimal medical treatment
The subjects will receive optimal medical treatment according up-to-date guidelines, including adequate antiplatelet therapy, statins, β-blocker and nitrates, plus angiotensin converting enzyme inhibitor(ACEI)/angiotensin receptor blocker(ARB),oral anticoagulants, if necessary.
Other Name: OMT
Active Comparator: Control arm
The subjects will be interviewed and have their baseline frequency and severity of angina pectoris recorded, then they will receive optimal medical treatment over 30 days.
Drug: Optimal medical treatment
The subjects will receive optimal medical treatment according up-to-date guidelines, including adequate antiplatelet therapy, statins, β-blocker and nitrates, plus angiotensin converting enzyme inhibitor(ACEI)/angiotensin receptor blocker(ARB),oral anticoagulants, if necessary.
Other Name: OMT

Detailed Description:
Refractory angina pectoris denotes "chronic stable angina that persists despite optimal medication and when revascularisation is unfeasible or where the risks are unjustified". These patients could potentially be relieved by non-conventional treatments like remote ischemic conditioning, and actually this effect has been observed in several cases in the center of the sponsor. This study is a pilot study to measure the efficacy and safety of this method in this group of patients.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosed angina pectoris that remains despite optimal medical treatment;
  • No chance of further revascularization or refusal to do revascularization;
  • The frequency and Canadian Cardiovascular Society (CCS) scale stays stable over the past 3 months before inclusion.

Exclusion Criteria:

  • Known or highly suspected abnormality of peripheral arteries, veins, or extremities;
  • Infection or fever in the past month;
  • Blood pressure over 180/110 millimeters of mercury (mmHg) or below 80/50mmHg;
  • Refusal to comply with the study protocol;
  • Currently under sulfonylureas or prostaglandins therapy;
  • Other conditions that the researchers judge as inappropriate to participate.
  Contacts and Locations
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): NCT02499250


Contacts
Contact: Li Zhao, MD,PhD 86-10-66951416 zhaoli463700@foxmail.com

Locations
China, Beijing
Heart Center, Navy General Hospital of PLA Recruiting
Beijing, Beijing, China, 100048
Contact: Zhong Yin, MD,PhD    86-10-66951519    ouandyin1219@163.com   
Sponsors and Collaborators
Navy General Hospital, Beijing
Investigators
Study Chair: Tianchang Li, MD, PhD Heart center, Navy General Hospital
  More Information

Responsible Party: Li Zhao MD,PhD, attending physician, Navy General Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02499250     History of Changes
Other Study ID Numbers: HZKY-PJ-2014-1-A
First Submitted: June 21, 2015
First Posted: July 16, 2015
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by Li Zhao MD,PhD, Navy General Hospital, Beijing:
refractory angina pectoris
remote ischemic conditioning
life quality
anxiety
depression
inflammation

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms