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Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events

26. maj 2020 opdateret af: yue deng, Changchun University of Chinese Medicine

Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1042

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jilin
      • Changchun, Jilin, Kina, 130000
        • Jilin Province TCM Institute of Chinese Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

treat with combination of standardized western medical drug therapy and Chinese medical continued treatment

Beskrivelse

Inclusion Criteria:

  1. the patients who are according with the II、III stage in CHD western medical diagnosis standard；
  2. age between 18 and 75(including 18 and 75)；
  3. Signed the informed consent voluntarily.

Exclusion Criteria:

  1. The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）；
  2. the patients who have myocardial infarction or vascular remodeling in last 3 months；
  3. hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）；
  4. the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/L and/ or random blood glucose>11.0mmol/L）；
  5. the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
  6. any other sever diseases such as malignant tumor；
  7. the patients who attending other clinical study in late 3 months；
  8. pregnant or lactating women；
  9. the patients who have allergic constitution or are allergic to many drugs.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Integrative Chinese and western medicine
Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study.
Western medicine
western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary end point all cause death
Tidsramme: up to 12 months
all because of death, stroke, nonfatal myocardial infarction, revascularization.
up to 12 months
Secondary endpoint hospitalization
Tidsramme: up to 12months
the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications
up to 12months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Angina symptoms
Tidsramme: up to 12months
Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.
up to 12months
electrocardiogram
Tidsramme: up to 12months
up to 12months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
safety indicators
Tidsramme: up to 12months
ALT ,AST,BUN,CR,blood routine examination,urine routine
up to 12months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Changchun University of Chinese Medicine

Efterforskere

  • Studiestol: deng yue, dirctor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2012

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

14. september 2012

Først indsendt, der opfyldte QC-kriterier

26. oktober 2012

Først opslået (Skøn)

29. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201007001-3-1

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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