Refractory Angina PectorisD-RIC-RAPNCT02499250
Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients
A study testing remote ischemic conditioning (TDFT-12-A2) and Optimal medical treatment in people with Refractory Angina Pectoris, run by Navy General Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Angina Pectoris
- What is being tested?
- remote ischemic conditioning (TDFT-12-A2) and Optimal medical treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Heart Center, Navy General Hospital of PLA
Beijing, Beijing Municipality, 100048
Zhong Yin, MD,PhD, 86-10-66951519, ouandyin1219@163.com
About this study
Official title: Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism
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.
Read the 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.
- Conditions
- Refractory Angina Pectoris
- Being tested
- remote ischemic conditioning (TDFT-12-A2), Optimal medical treatment
- Keywords
- refractory angina pectoris, remote ischemic conditioning, life quality, anxiety, depression, inflammation
- Medical subject headings
- Angina Pectoris, Anxiety Disorders, Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioning (TDFT-12-A2)Device
Also called RIC
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 treatmentDrug
Also called OMT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of angina pectoris onset
The total times of angina pectoris onset over one week
Measured: 30 days
Canadian Cardiovascular Society Angina Class
Ranging from class 1 to class 4 according to its definition
Measured: 30 days
Secondary outcomes (8)
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.
Measured: 30 days
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.
Measured: 30 days
Self-Rating Anxiety Scale
Reported as the Self-Rating Anxiety score
Measured: 30 days
Self-Rating Depression Scale
Reported as the Self-Rating Depression score
Measured: 30 days
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.
Measured: 30 days
Grip strength
Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.
Measured: 30 days
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.
Measured: 1,7 and 30 days
Circulating CD34+ progenitor cells
The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhao MD,PhD, Navy General Hospital, Beijing
- Investigators
- Tianchang Li, MD, PhD, Study chair, Heart center, Navy General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499250
- Sponsor's protocol ID
- HZKY-PJ-2014-1-A
- Acronym
- D-RIC-RAP
- Status last verified
- Jul 2015
- First submitted
- 21 Jun 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism
- ClinicalTrials.gov ID
- NCT02499250
- Acronym / sponsor ID
- D-RIC-RAP / HZKY-PJ-2014-1-A
- Conditions
- Refractory Angina Pectoris
- Keywords
- refractory angina pectoris, remote ischemic conditioning, life quality, anxiety, depression, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC arm | Experimental | Device: remote ischemic conditioning (TDFT-12-A2), Drug: Optimal medical treatmentThe 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 | Active comparator | Drug: Optimal medical treatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioning (TDFT-12-A2)Also: RICThe 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." | Device | RIPC arm |
| Optimal medical treatmentAlso: OMTThe 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. | Drug | Control arm, RIPC arm |
Primary outcome
Frequencies of angina pectoris onset
Time frame: 30 days
The total times of angina pectoris onset over one week
Canadian Cardiovascular Society Angina Class
Time frame: 30 days
Ranging from class 1 to class 4 according to its definition
8 secondary outcomes
Flow mediated vasodilation in percentage increase
Time frame: 30 days
Flow mediated vasodilation in absolute increase
Time frame: 30 days
Self-Rating Anxiety Scale
Time frame: 30 days
Self-Rating Depression Scale
Time frame: 30 days
Inflammatory cytokines expression
Time frame: 30 days
Grip strength
Time frame: 30 days
Skin and muscle abnormalities
Time frame: 1,7 and 30 days
Circulating CD34+ progenitor cells
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianchang Li, MD, PhD study chair
Heart center, Navy General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic conditioning (TDFT-12-A2) and Optimal medical treatment in people with Refractory Angina Pectoris, run by Navy General Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhao, MD,PhD (86-10-66951416, zhaoli463700@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of angina pectoris onset (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.