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

Refractory Angina Pectoris Clinical Trial

— D-RIC-RAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02499250
• Other study ID #: HZKY-PJ-2014-1-A
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2015
• Last updated: July 15, 2015
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2015
• Source: Navy General Hospital, Beijing
• Contact: Li Zhao, MD,PhD
• Phone: 86-10-66951416
• Email: zhaoli463700[@]foxmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina Pectoris

Intervention

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."

Drug:
• Optimal medical treatment
The subjects will receive optimal medical treatment according up-to-date guidelines, including adequate antiplatelet therapy, statins, ß-blocker and nitrates, plus angiotensin converting enzyme inhibitor(ACEI)/angiotensin receptor blocker(ARB),oral anticoagulants, if necessary.

Locations

Country	Name	City	State
China	Heart Center, Navy General Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of angina pectoris onset	The total times of angina pectoris onset over one week	30 days	No
Primary	Canadian Cardiovascular Society Angina Class	Ranging from class 1 to class 4 according to its definition	30 days	No
Secondary	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	No
Secondary	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	No
Secondary	Self-Rating Anxiety Scale	Reported as the Self-Rating Anxiety score	30 days	No
Secondary	Self-Rating Depression Scale	Reported as the Self-Rating Depression score	30 days	No
Secondary	Inflammatory cytokines expression	Reported as the serum levels of inflammatory cytokines measured by ELISA kits, including tumor necrosis factor(TNF-a),Interleukine(IL)-6,and IL-10; The expression of signaling proteins in separated blood mononuclear cells,including hypoxia inducible factor(HIF) 1a.	30 days	No
Secondary	Grip strength	Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.	30 days	Yes
Secondary	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	Yes
Secondary	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	No