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

Not Applicable

• Conditions: Refractory Angina Pectoris
• Interventions: Device: remote ischemic conditioning (TDFT-12-A2); Drug: Optimal medical treatment

• Registration Number: NCT02499250
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

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.

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-06-21
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16
• Primary Completion: 2016-06
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC arm	remote ischemic conditioning (TDFT-12-A2)	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.
Control arm	Optimal medical treatment	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.
RIPC arm	Optimal medical treatment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self-Rating Anxiety Scale	30 days	Reported as the Self-Rating Anxiety score
Flow mediated vasodilation in absolute increase	30 days	Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
Flow mediated vasodilation in percentage increase	30 days	Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
Grip strength	30 days	Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.
Circulating CD34+ progenitor cells	30 days	The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.
Self-Rating Depression Scale	30 days	Reported as the Self-Rating Depression score
Inflammatory cytokines expression	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.
Skin and muscle abnormalities	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.

Trial Locations

Locations (1)

Heart Center, Navy General Hospital of PLA; 🇨🇳 Beijing, Beijing, China