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

Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Angina Pectoris
• Intervention / Treatment: Device: remote ischemic conditioning (TDFT-12-A2); Drug: Optimal medical treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Zhao, MD,PhD; Phone Number: 86-10-66951416; Email: zhaoli463700@foxmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100048
      • Recruiting
      • Heart Center, Navy General Hospital of PLA
      • Contact: Zhong Yin, MD,PhD; Phone Number: 86-10-66951519; Email: ouandyin1219@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: OMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequencies of angina pectoris onset	The total times of angina pectoris onset over one week	30 days
Canadian Cardiovascular Society Angina Class	Ranging from class 1 to class 4 according to its definition	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow mediated vasodilation in percentage increase	Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.	30 days
Flow mediated vasodilation in absolute increase	Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.	30 days
Self-Rating Anxiety Scale	Reported as the Self-Rating Anxiety score	30 days
Self-Rating Depression Scale	Reported as the Self-Rating Depression score	30 days
Inflammatory cytokines expression	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.	30 days
Grip strength	Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.	30 days
Skin and muscle abnormalities	Whether or not the skin of the arm has bruises, and whether or not the arm has sore or pain feeling.	1,7 and 30 days
Circulating CD34+ progenitor cells	The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.	30 days

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing
• Investigators: Study Chair: Tianchang Li, MD, PhD, Heart center, Navy General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: June 21, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: depression; remote ischemic conditioning; anxiety; inflammation; life quality; refractory angina pectoris
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: HZKY-PJ-2014-1-A