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The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients

31 juli 2016 bijgewerkt door: Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine

The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention

The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Guangdong
      • GuangZhou, Guangdong, China
        • Werving
        • Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Huizheng Zhu, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
  2. Postoperative routine drug treatment
  3. Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
  4. Aged 35 to 75 years old
  5. Must sign a consent form.

Exclusion Criteria:

  1. Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
  2. With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
  3. Serious cardiac insufficiency (EF < 35%)
  4. Uncontrolled patients with high blood pressure
  5. Merger or severe valvular heart disease in acute cerebrovascular disease
  6. Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
  7. Patients with severe mental illness
  8. Patients with malignant tumor or life expectancy in less than three years
  9. Patients with severe hematopoietic system disease
  10. Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
  11. Pregnancy or ready to pregnant women, nursing mothers;
  12. Participated in nearly three months, or is in other clinical subjects . -

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Tongguan capsule
Tongguan capsule (0.5 g tid. for 6 months)
Geneesmiddel: Tongguan capsule
eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
Placebo-vergelijker: placebo capsule
same volume/day of placebo capsule (0.5 g tid. for 6 months)
Geneesmiddel: placebo capsule
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
miRNAs spectrum
Tijdsspanne: six months
Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
six months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
major adverse cardiac event
Tijdsspanne: six months
frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)
six months
Renin predicts cardiovascular homeostasis and ventricular remodeling
Tijdsspanne: 6 months
renin（ng/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
6 months
Ang II predicts cardiovascular homeostasis and ventricular remodeling
Tijdsspanne: 6 months
Ang II（pg/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
6 months
Serum E
Tijdsspanne: 6 months
Acute coronary syndrome is caused by atherosclerotic plaque instability and rupture. The stability of plaque is closely related to inflammation.Serum E (pmol / L) is an important pathway of various immune and inflammatory regulation, which promotes the development of atherosclerosis and is a risk factor for atherosclerosis.
6 months
Inflammatory mediators
Tijdsspanne: 6 months
Tumor Necrosis factor alpha (ng/L)and Interleukin-6，IL-6 (ng/L) measure of the general situation of patients
6 months
Brain Natriuretic Peptide
Tijdsspanne: 6 months
B-type natriuretic peptide（pg/ml） is a neurohormone synthesized in the cardiac ventricles upon ventricular pressure overload and ventricular dilatation
6 months
Echocardiography measure of left ventricular systolic function
Tijdsspanne: 6 months
Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
6 months
Echocardiography measure of left ventricular diastolic function
Tijdsspanne: 6 months
Left ventricular end diastolic diameter (LVEDD) (mm )measure of left ventricular diastolic function in patients
6 months
New York Heart Association functional classification
Tijdsspanne: 6 months
I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
6 months
Coronary angiography
Tijdsspanne: 6 months

Quantitative coronary angiography in the stenosis degree, 25%, 50%, 75%, 90%, 99%, 100%, 1, 2, 4, 6, 8,, 16, 32, and, respectively.

Scoring multiplication will segment coefficients corresponding to the degree of stenosis and the stenosis of total score that is the sum of Gensini score of coronary artery stenosis in the patients.
6 months
Seattle Angina-vragenlijstscore
Tijdsspanne: 6 maanden
De Seattle Angina Questionnaire is een geldig en betrouwbaar instrument dat vijf klinisch belangrijke gezondheidsdimensies meet bij patiënten met coronaire hartziekte (fysieke beperking, anginastabiliteit, anginafrequentie, behandelingstevredenheid en ziekteperceptie). (in eenheden op een schaal).
6 maanden
The traditional Chinese medicine syndrome scale
Tijdsspanne: 6 months
The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with traditional Chinese medicine syndrome type
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Onderzoekers

  • Studie directeur: Minzhou Zhang, MD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
  • Hoofdonderzoeker: Huizheng Zhu, PhD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2016

Primaire voltooiing (Verwacht)

1 september 2017

Studie voltooiing (Verwacht)

1 december 2017

Studieregistratiedata

Eerst ingediend

21 juli 2016

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2016

Eerst geplaatst (Schatting)

1 augustus 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

2 augustus 2016

Laatste update ingediend die voldeed aan QC-criteria

31 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • B2015-129-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

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