Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 33639 for:    value

Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02755207
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).

Condition or disease
Acute Coronary Syndrome

Detailed Description:

The present study is a single-center, prospective diagnostic study among patients presenting to the ED or ICU within 24 h of onset of chest pain suggestive of suspected ACS.

We propose to construct the biobank of ACS and evaluate the potential diagnostic value of circulating microRNAs compared with cTnI for suspected ACS patients. All the patients are to be followed up for 6 months. Final diagnosis was made by an expert panel cardiologist, based on all available clinical information including cTnI measurements, ECG, coronary angiography, cardiac exercise tests and information from hospital discharge letters.

The concentrations of microRNAs will be evaluated by quantitative reverse transcription PCR, using highly specific primers and hybridization probes.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
Suspected ACS group
Patients admitted to the hospital with the diagnosis of ACS
Blank control group
Patients admitted to the hospital without the diagnosis of ACS



Primary Outcome Measures :
  1. Evaluate the diagnostic value of microRNAs in qPCR,in ACS [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Evaluate the prognostic value of microRNAs in ACS [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Suspected ACS patients (STEMI, NSTEMI, and UA)
Criteria

Inclusion Criteria:

Suspected ACS patients (STEMI, NSTEMI, and UA):

Age>18 years; Informed consent.

Exclusion Criteria:

Patients who will undergo immediate PCI; Pregnant and lactating women; Patients with mental disorders; Patients are using other experimental drugs; Refusal to provide informed.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755207


Contacts
Layout table for location contacts
Contact: bin he hebinicu@139.com
Contact: huimin cao 150128433@qq.com

Locations
Layout table for location information
China, Shanghai
Ethics Committee of Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: Guangyu Chen, PhD    +86-02125076143    xinhuacru@163.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Layout table for additonal information
Responsible Party: Bin He, M.D./Ph.D., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02755207     History of Changes
Other Study ID Numbers: XH-16-003
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases