- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02850627
The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
31 juli 2016 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Förväntat)
100
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Guangdong
-
GuangZhou, Guangdong, Kina
- Rekrytering
- Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
-
Kontakt:
- Minzhou Zhang, MD
- Telefonnummer: 32808 86-20-81887233
- E-post: 1542377671@qq.com
-
Huvudutredare:
- Huizheng Zhu, PhD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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-jämförare: 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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
miRNAs spectrum
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
major adverse cardiac event
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
|
Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
|
6 months
|
Echocardiography measure of left ventricular diastolic function
Tidsram: 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
Tidsram: 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
Tidsram: 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 poäng
Tidsram: 6 månader
|
Seattle Angina Questionnaire är ett giltigt och tillförlitligt instrument som mäter fem kliniskt viktiga dimensioner av hälsa hos patienter med kranskärlssjukdom (fysisk begränsning, kärlkrampstabilitet, kärlkrampsfrekvens, behandlingstillfredsställelse och sjukdomsuppfattning).
(i enheter på en skala).
|
6 månader
|
The traditional Chinese medicine syndrome scale
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Minzhou Zhang, MD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
- Huvudutredare: Huizheng Zhu, PhD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Förväntat)
1 september 2017
Avslutad studie (Förväntat)
1 december 2017
Studieregistreringsdatum
Först inskickad
21 juli 2016
Först inskickad som uppfyllde QC-kriterierna
27 juli 2016
Första postat (Uppskatta)
1 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B2015-129-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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