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

Primary Purpose

Refractory Angina Pectoris

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning (TDFT-12-A2)
Optimal medical treatment
Sponsored by
Navy General Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Refractory Angina Pectoris focused on measuring refractory angina pectoris, remote ischemic conditioning, life quality, anxiety, depression, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heart Center, Navy General Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RIPC arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Self-Rating Anxiety Scale
Reported as the Self-Rating Anxiety score
Self-Rating Depression Scale
Reported as the Self-Rating Depression score
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.
Grip strength
Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.
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.
Circulating CD34+ progenitor cells
The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.

Full Information

First Posted
June 21, 2015
Last Updated
July 15, 2015
Sponsor
Navy General Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02499250
Brief Title
Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients
Acronym
D-RIC-RAP
Official Title
Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Angina Pectoris
Keywords
refractory angina pectoris, remote ischemic conditioning, life quality, anxiety, depression, inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPC arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
remote ischemic conditioning (TDFT-12-A2)
Other Intervention Name(s)
RIC
Intervention Description
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."
Intervention Type
Drug
Intervention Name(s)
Optimal medical treatment
Other Intervention Name(s)
OMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequencies of angina pectoris onset
Description
The total times of angina pectoris onset over one week
Time Frame
30 days
Title
Canadian Cardiovascular Society Angina Class
Description
Ranging from class 1 to class 4 according to its definition
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Flow mediated vasodilation in percentage increase
Description
Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
Time Frame
30 days
Title
Flow mediated vasodilation in absolute increase
Description
Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
Time Frame
30 days
Title
Self-Rating Anxiety Scale
Description
Reported as the Self-Rating Anxiety score
Time Frame
30 days
Title
Self-Rating Depression Scale
Description
Reported as the Self-Rating Depression score
Time Frame
30 days
Title
Inflammatory cytokines expression
Description
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.
Time Frame
30 days
Title
Grip strength
Description
Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.
Time Frame
30 days
Title
Skin and muscle abnormalities
Description
Whether or not the skin of the arm has bruises, and whether or not the arm has sore or pain feeling.
Time Frame
1,7 and 30 days
Title
Circulating CD34+ progenitor cells
Description
The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhao, MD,PhD
Phone
86-10-66951416
Email
zhaoli463700@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianchang Li, MD, PhD
Organizational Affiliation
Heart center, Navy General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center, Navy General Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Yin, MD,PhD
Phone
86-10-66951519
Email
ouandyin1219@163.com

12. IPD Sharing Statement

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

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