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

NCT ID: NCT02499250

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Refractory Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

remote ischemic conditioning (TDFT-12-A2)

Intervention Type DEVICE

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."

Optimal medical treatment

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Optimal medical treatment

Intervention Type DRUG

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.

Interventions

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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."

Intervention Type DEVICE

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.

Intervention Type DRUG

Other Intervention Names

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RIC OMT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Li Zhao MD,PhD

attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tianchang Li, MD, PhD

Role: STUDY_CHAIR

Heart center, Navy General Hospital

Locations

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Heart Center, Navy General Hospital of PLA

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Zhao, MD,PhD

Role: CONTACT

86-10-66951416

Facility Contacts

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Zhong Yin, MD,PhD

Role: primary

86-10-66951519

Other Identifiers

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HZKY-PJ-2014-1-A

Identifier Type: -

Identifier Source: org_study_id

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