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

1. august 2019 oppdatert av: Jianqiao Fang, Zhejiang Chinese Medical University
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 microcirculatory characteristics of meridian phenomenon for the Heart and Lung meridians by using laser doppler. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

This study will include 40 patients diagnosed with chronic stable angina pectoris (CSAP) and 40 healthy volunteers. Laser doppler examination will be adopted to assess the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. In addition, by comparing microcirculation in the acupoints along the Heart and Lung meridians, the relative specificity of the two meridians will also be investigated. Primary outcomes will be blood flow curve and blood perfusion units(PU). Furthermore, this study will build standardized techniques and schemes for detecting the microcirculatory characteristics of meridian phenomenon for Heart and Lung. The results of this study could also provide scientific foundation for traditional meridian theories.

Studietype

Observasjonsmessig

Registrering (Forventet)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Zhejiang
      • Hanzhou, Zhejiang, Kina, 310000
        • Rekruttering
        • The Third Affiliated hospital of Zhejiang Chinese Medical University
        • Hovedetterforsker:
          • Jianqiao Fang

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

Inclusion criteria for CSAP

  1. 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);
  2. Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
  3. The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
  4. 35 ≤ age ≤65 years, male or female;
  5. Patients have clear consciousness and could communicate with others normally;
  6. Patients could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin.

Inclusion criteria for health volunteers

  1. 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;
  2. 35 ≤ age ≤65 years, male or female;
  3. Participants have clear consciousness and could communicate with others normally;
  4. Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.

Exclusion Criteria:

Exclusion criteria for CSAP

  1. 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);
  2. Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
  3. Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
  4. Patients have concomitant conditions of lung diseases, such as chronic obstructive pulmonary disease (COPD) ;
  5. Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;
  6. Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;
  7. Pregnant or lactating patients;
  8. Patients are participating in other trials.

Exclusion criteria of health volunteers

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
CSAP gruppe
Denne gruppen vil omfatte 40 pasienter med kronisk stabil angina pectoris (CSAP).

Laser doppler will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.

  1. Experimental device: Four-channel laser doppler flowmetry (PeriFlux System 5000, Sweden).
  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 and normal breath and avoid limb movement during the whole measuring period. The probes will be left at 4 measuring sites. Blood flow curve will be recorded constantly using Perisoft software (PeriFlux, Sweden). Microcirculatory flux in the measuring sites will be calculated [Perfusion units (PU) =concentration of moving blood cells (CMBC)×velocity (V)]. The acupoint microcirculation 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
Frisk gruppe
Denne gruppen vil omfatte 40 friske frivillige.

Laser doppler will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.

  1. Experimental device: Four-channel laser doppler flowmetry (PeriFlux System 5000, Sweden).
  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 and normal breath and avoid limb movement during the whole measuring period. The probes will be left at 4 measuring sites. Blood flow curve will be recorded constantly using Perisoft software (PeriFlux, Sweden). Microcirculatory flux in the measuring sites will be calculated [Perfusion units (PU) =concentration of moving blood cells (CMBC)×velocity (V)]. The acupoint microcirculation 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood flow curve
Tidsramme: 5 minutes
The blood flow curve could reflect the microcirculatory flux in the measuring sites
5 minutes
Blood perfusion units
Tidsramme: 5 minutes
Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)
5 minutes

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2019

Primær fullføring (Forventet)

1. desember 2020

Studiet fullført (Forventet)

1. desember 2021

Datoer for studieregistrering

Først innsendt

26. juli 2019

Først innsendt som oppfylte QC-kriteriene

30. juli 2019

Først lagt ut (Faktiske)

1. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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