The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
31. juli 2016 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Guangdong
-
GuangZhou, Guangdong, Kina
- Rekruttering
- Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
-
Kontakt:
- Minzhou Zhang, MD
- Telefonnummer: 32808 86-20-81887233
- E-mail: 1542377671@qq.com
-
Ledende efterforsker:
- Huizheng Zhu, PhD
-
-
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
35 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
- Postoperative routine drug treatment
- Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
- Aged 35 to 75 years old
- Must sign a consent form.
Exclusion Criteria:
- Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
- With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
- Serious cardiac insufficiency (EF < 35%)
- Uncontrolled patients with high blood pressure
- Merger or severe valvular heart disease in acute cerebrovascular disease
- Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
- Patients with severe mental illness
- Patients with malignant tumor or life expectancy in less than three years
- Patients with severe hematopoietic system disease
- Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
- Pregnancy or ready to pregnant women, nursing mothers;
- Participated in nearly three months, or is in other clinical subjects . -
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tongguan capsule
Tongguan capsule (0.5 g tid.
for 6 months)
|
eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
|
|
Placebo komparator: placebo capsule
same volume/day of placebo capsule (0.5 g tid.
for 6 months)
|
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
miRNAs spectrum
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
major adverse cardiac event
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
|
Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
|
6 months
|
|
Echocardiography measure of left ventricular diastolic function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 Questionnaire score
Tidsramme: 6 måneder
|
Seattle Angina Questionnaire er et gyldigt og pålideligt instrument, der måler fem klinisk vigtige dimensioner af sundhed hos patienter med kranspulsåresygdom (fysisk begrænsning, anginastabilitet, anginafrekvens, behandlingstilfredshed og sygdomsopfattelse).
(i enheder på en skala).
|
6 måneder
|
|
The traditional Chinese medicine syndrome scale
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Minzhou Zhang, MD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
- Ledende efterforsker: Huizheng Zhu, PhD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
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
1. juli 2016
Primær færdiggørelse (Forventet)
1. september 2017
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
21. juli 2016
Først indsendt, der opfyldte QC-kriterier
27. juli 2016
Først opslået (Skøn)
1. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2015-129-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
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