Chronic Stable Angina PectorisNCT04041245

A Study on the Metabolic Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Stable Angina Pectoris

An observational study of Chronic Stable Angina Pectoris, run by Zhejiang Chinese Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Chronic Stable Angina Pectoris
What is being tested?: Near infrared spectroscopy
Type of treatment: Medical device
How many people: 80 participants
Where: 1 siteChina
Study dates: 1 Jun 2019to Dec 2021
Phase: Observational
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 35 to 65 years
All sexes
Adult, Older adult

Study population: 40 patients with chronic stable angina pectoris (CSAP) and 40 healthy volunteer.

Who may be able to join

Patients should meet the diagnostic criteria of coronary heart disease, which includes the following items: 1)confirmed old myocardial infarction (MI), or a history of percutaneous coronary intervention(PCI), or coronary artery bypass grafting; 2)50% or more luminal stenosis in at least one coronary artery or major branch segment confirmed by coronary angiogram or CT angiography; 3) myocardial ischemia indicted by exercise stress radionuclide myocardial imaging; 4) treadmill exercise testing is positive (for male patients);
Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
35 ≤ age ≤65 years, male or female;
Patients have clear consciousness and could communicate with others normally;
Patients could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin.

Show all 10Show fewer

Healthy volunteers who could provide a recent (in the past 3 month) medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
35 ≤ age ≤65 years, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.

Who cannot join

Patients with acute coronary syndrome (including acute myocardial infarction and unstable angina) and severe arrhythmias (such as severe atrioventricular block, ventricular tachycardia, supraventricular tachycardia, frequent premature beats and premature ventricular contraction);
Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
Patients have concomitant conditions of lung diseases, such as COPD;
Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;
Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;

Show all 12Show fewer

Pregnant or lactating patients;
Patients are participating in other trials.
Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
Pregnant or lactating participants ;
Participants are participating in other trials.

Trial locations and contacts

1 site in 1 country.

Yongliang Jiang, Ph.D contact

Hantong Hu contact

China1 site, 1 recruiting

the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, 310000
Hantong Hu, 86-18667103032, 413351308@qq.com
Xiaoyu Li, 86-15017541803, 752616172@qq.com
Recruiting

Other trials in China

About this study

Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the metabolic characteristics of meridian phenomenon for the Heart and Lung meridians by using near infrared spectroscopy. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

Read the detailed description

This study will include 40 patients diagnosed with chronic stable angina pectoris (CSAP) and 40 healthy volunteers. Near infrared spectroscopy will be adopted to assess the metabolic characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. In addition, by comparing the metabolic characteristics in the acupoints along the Heart and Lung meridians, the relative specificity of the two meridians will also be investigated.

Primary outcomes will be regional oxygen saturation (rSO2). Furthermore, this study will build standardized techniques and schemes for detecting the metabolic characteristics of meridian phenomenon for Heart and Lung. The results of this study could also provide scientific foundation for traditional meridian theories.

Conditions: Chronic Stable Angina Pectoris
Being tested: Near infrared spectroscopy
Keywords: meridians, acupuncture, chronic stable angina pectoris, meridian phenomenon, near infrared spectroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Near infrared spectroscopyDevice
Near infrared spectroscopy will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.
1. Experimental device: a four-channel INVOS 5100C Oximeter (Somanetics Corp., Troy, USA)
2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination. They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. After ripping the transparent adhesive tape on the probe, the probes will be left at 4 measuring sites. Regional oxygen saturation (rSO2) will be recorded for 5 minutes.
3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.

Study groups in NCT04041245
Study group	Role	What they receive
CSAP group		This group will include 40 patients with chronic stable angina pectoris (CSAP). Receives: Device: Near infrared spectroscopy
Healthy group		This group will include 40 healthy volunteers. Receives: Device: Near infrared spectroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Regional oxygen saturation (rSO2)
Regional oxygen saturation could reflect the metabolic characteristics of meridians phenomenon.
Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 2019Dec 2021

First posted1 Aug 2019
Study start1 Jun 2019
Primary completionDec 2020 (estimated)
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Chronic Stable 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04041245
Sponsor's protocol ID: 2019ZY002-MERIDIAN
Status last verified: Aug 2019
First submitted: 26 Jul 2019
Last updated: 6 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Litscher G, Wang L. [Cerebral near infrared spectroscopy and acupuncture--results of a pilot study]. Biomed Tech (Berl). 2000 Jul-Aug;45(7-8):215-8. doi: 10.1515/bmte.2000.45.7-8.215. German.
PubMed 10975151
Raith W, Pichler G, Sapetschnig I, Avian A, Sommer C, Baik N, Koestenberger M, Schmolzer GM, Urlesberger B. Near-infrared spectroscopy for objectifying cerebral effects of laser acupuncture in term and preterm neonates. Evid Based Complement Alternat Med. 2013;2013:346852. doi: 10.1155/2013/346852. Epub 2013 May 15.
PubMed 23762122
Litscher G, Wang L, Huber E. [Changes in cerebral near infrared spectroscopy parameters during manual acupuncture needle stimulation]. Biomed Tech (Berl). 2002 Apr;47(4):76-9. doi: 10.1515/bmte.2002.47.4.76. German.
PubMed 12051136
Takamoto K, Hori E, Urakawa S, Sakai S, Ishikawa A, Kohno S, Ono T, Nishijo H. Cerebral hemodynamic responses induced by specific acupuncture sensations during needling at trigger points: a near-infrared spectroscopic study. Brain Topogr. 2010 Sep;23(3):279-91. doi: 10.1007/s10548-010-0148-8. Epub 2010 May 26.
PubMed 20502956
Litscher G, Wang L, Schwarz G, Schikora D. [Increases of intracranial pressure and changes of blood flow velocity due to acupressure, needle and laser needle acupuncture?]. Forsch Komplementarmed Klass Naturheilkd. 2005 Aug;12(4):190-5. doi: 10.1159/000087044. Epub 2005 Aug 29. German.
PubMed 16137980
Litscher G, Schwarz G, Sandner-Kiesling A, Hadolt I, Eger E. Effects of acupuncture on the oxygenation of cerebral tissue. Neurol Res. 1998;20 Suppl 1:S28-32. doi: 10.1080/01616412.1998.11740605.
PubMed 9584920
Ohkubo M, Hamaoka T, Niwayama M, Murase N, Osada T, Kime R, Kurosawa Y, Sakamoto A, Katsumura T. Local increase in trapezius muscle oxygenation during and after acupuncture. Dyn Med. 2009 Mar 16;8:2. doi: 10.1186/1476-5918-8-2.
PubMed 19291290
Litscher G, Ofner M, He W, Wang L, Gaischek I. Acupressure at the Meridian Acupoint Xiyangguan (GB33) Influences Near-Infrared Spectroscopic Parameters (Regional Oxygen Saturation) in Deeper Tissue of the Knee in Healthy Volunteers. Evid Based Complement Alternat Med. 2013;2013:370341. doi: 10.1155/2013/370341. Epub 2013 Feb 7.
PubMed 23476689
Banzer W, Hubscher M, Seib M, Vogt L. Short-time effects of laser needle stimulation on the peripheral microcirculation assessed by laser Doppler spectroscopy and near-infrared spectroscopy. Photomed Laser Surg. 2006 Oct;24(5):575-80. doi: 10.1089/pho.2006.24.575.
PubMed 17069486
Jimbo S, Atsuta Y, Kobayashi T, Matsuno T. Effects of dry needling at tender points for neck pain (Japanese: katakori): near-infrared spectroscopy for monitoring muscular oxygenation of the trapezius. J Orthop Sci. 2008 Mar;13(2):101-6. doi: 10.1007/s00776-007-1209-z. Epub 2008 Apr 8.
PubMed 18392913
Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
PubMed 20007987

Want to know more?

Yongliang Jiang, Ph.D

86-13858173136

jyl2182@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
Active, not recruiting
SELUTION 4 De Novo Small Vessel IDE Trial
Coronary Artery Disease
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
Not yet recruiting
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography
Angina (Stable), Percutaneous Coronary Intervention (PCI)

All Chronic Stable Angina Pectoris trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Metabolic Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Stable Angina Pectoris
ClinicalTrials.gov ID: NCT04041245
Acronym / sponsor ID: 2019ZY002-MERIDIAN
Conditions: Chronic Stable Angina Pectoris
Keywords: meridians, acupuncture, chronic stable angina pectoris, meridian phenomenon, near infrared spectroscopy
Study type: Observational
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Zhejiang Chinese Medical UniversityOther government
Collaborators: The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University
Study start: 1 Jun 2019 (actual)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 1 Aug 2019 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
CSAP group	–	Device: Near infrared spectroscopyThis group will include 40 patients with chronic stable angina pectoris (CSAP).
Healthy group	–	Device: Near infrared spectroscopyThis group will include 40 healthy volunteers.

Who may qualify

Ages: 35 to 65 years
Sex: All
Age groups: Adult, Older adult
Study population: 40 patients with chronic stable angina pectoris (CSAP) and 40 healthy volunteer.

Key inclusion criteria (10 listed)

Patients should meet the diagnostic criteria of coronary heart disease, which includes the following items: 1)confirmed old myocardial infarction (MI), or a history of percutaneous coronary intervention(PCI), or coronary artery bypass grafting; 2)50% or more luminal stenosis in at least one coronary artery or major branch segment confirmed by coronary angiogram or CT angiography; 3) myocardial ischemia indicted by exercise stress radionuclide myocardial imaging; 4) treadmill exercise testing is positive (for male patients);
Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
35 ≤ age ≤65 years, male or female;
Patients have clear consciousness and could communicate with others normally;

Key exclusion criteria (12 listed)

Patients with acute coronary syndrome (including acute myocardial infarction and unstable angina) and severe arrhythmias (such as severe atrioventricular block, ventricular tachycardia, supraventricular tachycardia, frequent premature beats and premature ventricular contraction);
Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
Patients have concomitant conditions of lung diseases, such as COPD;
Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;

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
Near infrared spectroscopyNear infrared spectroscopy will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups. 1. Experimental device: a four-channel INVOS 5100C Oximeter (Somanetics Corp., Troy, USA) 2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination. They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. After ripping the transparent adhesive tape on the probe, the probes will be left at 4 measuring sites. Regional oxygen saturation (rSO2) will be recorded for 5 minutes. 3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.	Device	CSAP group, Healthy group

Primary outcome

Regional oxygen saturation (rSO2)
Time frame: 5 minutes
Regional oxygen saturation could reflect the metabolic characteristics of meridians phenomenon.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
Background: PubMed 10975151Litscher G, Wang L. [Cerebral near infrared spectroscopy and acupuncture--results of a pilot study]. Biomed Tech (Berl). 2000 Jul-Aug;45(7-8):215-8. doi: 10.1515/bmte.2000.45.7-8.215. German.
Background: PubMed 23762122Raith W, Pichler G, Sapetschnig I, Avian A, Sommer C, Baik N, Koestenberger M, Schmolzer GM, Urlesberger B. Near-infrared spectroscopy for objectifying cerebral effects of laser acupuncture in term and preterm neonates. Evid Based Complement Alternat Med. 2013;2013:346852. doi: 10.1155/2013/346852. Epub 2013 May 15.
Background: PubMed 12051136Litscher G, Wang L, Huber E. [Changes in cerebral near infrared spectroscopy parameters during manual acupuncture needle stimulation]. Biomed Tech (Berl). 2002 Apr;47(4):76-9. doi: 10.1515/bmte.2002.47.4.76. German.
Background: PubMed 20502956Takamoto K, Hori E, Urakawa S, Sakai S, Ishikawa A, Kohno S, Ono T, Nishijo H. Cerebral hemodynamic responses induced by specific acupuncture sensations during needling at trigger points: a near-infrared spectroscopic study. Brain Topogr. 2010 Sep;23(3):279-91. doi: 10.1007/s10548-010-0148-8. Epub 2010 May 26.
Background: PubMed 16137980Litscher G, Wang L, Schwarz G, Schikora D. [Increases of intracranial pressure and changes of blood flow velocity due to acupressure, needle and laser needle acupuncture?]. Forsch Komplementarmed Klass Naturheilkd. 2005 Aug;12(4):190-5. doi: 10.1159/000087044. Epub 2005 Aug 29. German.
Background: PubMed 9584920Litscher G, Schwarz G, Sandner-Kiesling A, Hadolt I, Eger E. Effects of acupuncture on the oxygenation of cerebral tissue. Neurol Res. 1998;20 Suppl 1:S28-32. doi: 10.1080/01616412.1998.11740605.
Background: PubMed 19291290Ohkubo M, Hamaoka T, Niwayama M, Murase N, Osada T, Kime R, Kurosawa Y, Sakamoto A, Katsumura T. Local increase in trapezius muscle oxygenation during and after acupuncture. Dyn Med. 2009 Mar 16;8:2. doi: 10.1186/1476-5918-8-2.
Background: PubMed 23476689Litscher G, Ofner M, He W, Wang L, Gaischek I. Acupressure at the Meridian Acupoint Xiyangguan (GB33) Influences Near-Infrared Spectroscopic Parameters (Regional Oxygen Saturation) in Deeper Tissue of the Knee in Healthy Volunteers. Evid Based Complement Alternat Med. 2013;2013:370341. doi: 10.1155/2013/370341. Epub 2013 Feb 7.
Background: PubMed 17069486Banzer W, Hubscher M, Seib M, Vogt L. Short-time effects of laser needle stimulation on the peripheral microcirculation assessed by laser Doppler spectroscopy and near-infrared spectroscopy. Photomed Laser Surg. 2006 Oct;24(5):575-80. doi: 10.1089/pho.2006.24.575.
Background: PubMed 18392913Jimbo S, Atsuta Y, Kobayashi T, Matsuno T. Effects of dry needling at tender points for neck pain (Japanese: katakori): near-infrared spectroscopy for monitoring muscular oxygenation of the trapezius. J Orthop Sci. 2008 Mar;13(2):101-6. doi: 10.1007/s00776-007-1209-z. Epub 2008 Apr 8.
Background: PubMed 20007987Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
Individual participant dataSharing planned: No

Related trials for Chronic Stable Angina Pectoris

Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
Active, not recruiting
SELUTION 4 De Novo Small Vessel IDE Trial
Coronary Artery Disease
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
Not yet recruiting
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography
Angina (Stable), Percutaneous Coronary Intervention (PCI)

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.

Yongliang Jiang, Ph.D contact

Hantong Hu contact

Jianqiao Fang, Ph.D principal investigator

Zhejiang Chinese Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Stable Angina Pectoris, run by Zhejiang Chinese Medical University 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 10 inclusion and 12 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 6 Aug 2019. 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 Yongliang Jiang, Ph.D (86-13858173136, jyl2182@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional oxygen saturation (rSO2) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04041245, which also lists 11 linked publications.

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 6 Aug 2019.