NCT04817748

Brief Summary

To find new biomarkers through Metabonomics Study of different types of myocardial infarction in Different Time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 13, 2021

Last Update Submit

March 23, 2021

Conditions

Myocardial Infarction

Keywords

myocardial infarctionmetabolomicsbiomarkers

Outcome Measures

Primary Outcomes (1)

  • metabolites molecules

    Detection of small molecular metabolites in blood by liquid chromatography mass spectrometry and gas chromatography mass spectrometry

    6 months

Study Arms (4)

Acute ST segment elevation myocardial infarction（STEMI）

the patients' coronary and venous blood were drawn for metabolomics study

Acute non ST segment elevation myocardial infarction（NSTEMI）

the patients' coronary and venous blood were drawn for metabolomics study

Acute myocardial infarction with no obstructive coronary atherosclerosis（MINOCA）

the patients' coronary and venous blood were drawn for metabolomics study

Patients with normal coronary artery（NCA)

the patients' coronary and venous blood were drawn for metabolomics study

Eligibility Criteria

Age20 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Different types of myocardial infarction were identified according to the international definition of myocardial infarction and 2020 guidelines and consensus on myocardial infarction. 2. Patients with normal coronary arteries were determined according to the results of coronary angiography.

You may qualify if:

  • The patient clearly had acute myocardial infarction. 2.The patient's serum cardiac markers (mainly troponin) were elevated (at least above the upper limit of 99% reference value) and accompanied by one of the following clinical indicators：
  • Ischemic symptoms
  • New ischemic ECG changes, new ST-T changes or left bundle branch block（LBBB）.
  • Pathological Q wave formation in ECG
  • Imaging evidence showed new loss of myocardial activity or new regional wall motion abnormalities.
  • The thrombus was confirmed by coronary angiography. 3．The patient had chest pain symptoms, but coronary angiography showed normal coronary artery (such as intercostal neuralgia, cervical spondylosis, chest pain of unknown origin, etc.)

You may not qualify if:

  • Refusal to sign informed consent.
  • Surgical treatment was performed in the last three months.
  • Patients with a history of the following diseases or consider the diagnosis of the following diseases：Stress cardiomyopathy, myocarditis, pericarditis, pneumonia, pulmonary embolism, aortic dissection.
  • Severe heart failure, grade IV cardiac function.
  • Liver and kidney dysfunction.
  • blood-borne diseases, including HIV / AIDS, hepatitis B, hepatitis C, etc.
  • Patients with a history of malignancies, autoimmune diseases, severe infectious diseases and trauma.
  • Previous history of myocardial infarction and stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yi Zhang

Shanghai, Shanghai Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood extract plasma

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yi Zhang, MD

    Department of Cardiology, Shanghai Tenth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Zhang, MD

CONTACT

18917686332yizshcn@gmail.com

Zheng Liu, MD

CONTACT

1852152636418521526364@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cardiology department of shanghai 10th people's hospital

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 26, 2021

Study Start

November 17, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations

CN(1)