NCT02499250

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

June 21, 2015

Last Update Submit

July 15, 2015

Conditions

Refractory Angina Pectoris

Keywords

refractory angina pectorisremote ischemic conditioninglife qualityanxietydepressioninflammation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Flow mediated vasodilation in percentage increase

    30 days

  • Flow mediated vasodilation in absolute increase

    30 days

  • Self-Rating Anxiety Scale

    30 days

  • Self-Rating Depression Scale

    30 days

  • Inflammatory cytokines expression

    30 days

  • +3 more secondary outcomes

Study Arms (2)

RIPC arm

EXPERIMENTAL

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)Drug: Optimal medical treatment

Control arm

ACTIVE COMPARATOR

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

Interventions

remote ischemic conditioning (TDFT-12-A2)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."

Also known as: RIC
RIPC arm
Optimal medical treatmentDRUG

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.

Also known as: OMT
Control armRIPC arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed angina pectoris that remains despite optimal medical treatment;
  • No chance of further revascularization or refusal to do revascularization;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center, Navy General Hospital of PLA

Beijing, Beijing Municipality, 100048, China

RECRUITING

MeSH Terms

Conditions

Angina PectorisAnxiety DisordersDepressionInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorPathologic Processes

Study Officials

  • Tianchang Li, MD, PhD

    Heart center, Navy General Hospital

    STUDY CHAIR

Central Study Contacts

Li Zhao, MD,PhD

CONTACT

86-10-66951416zhaoli463700@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician

Study Record Dates

First Submitted

June 21, 2015

First Posted

July 16, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

CN(1)