Acute Coronary SyndromeNCT01964313
Acute Coronary Syndrome Genetic Study
An observational study of Acute Coronary Syndrome, run by Peking University First Hospital at 1 site in China.
Trial summary
To describe the role of genetic factors and its relationship and interaction with environmental factors in the recurrence of cardiac events in Chinese patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 3,422 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from 75 hospitals in China.
Who may be able to join
- Written informed consent has been provided.
- Contact Order Form has been provided.
- Aged 18 years or older.
- Diagnosis of STEMI, NSTEMI or UA using the following definitions:
- Criteria for STEMI diagnosis:
- History of chest pain/discomfort and
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- Persistent ST-segment elevation (> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission and
- Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit.
- Criteria for NSTEMI diagnosis:
- History of chest pain/discomfort and
- Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances and
- Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit.
- Criteria for Unstable Angina diagnosis:
- Symptoms of angina at rest or on minimal exercise and
- At least 0.5mm ST deviation in at least 2 leads and
- No increase in biomarkers of necrosis
- OR objective evidence of ischaemia by non-invasive imaging OR significant coronary stenosis as determined by the treating physician at angiography if this is standard practice in study site.
- Hospitalized within 48 hours of onset of symptoms.
Who cannot join
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
- UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
- Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
- Current participation in a randomised interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First hospital
Beijing, Beijing Municipality, 100034
Jie Jiang
Jie Jiang, MD
About this study
Official title: Comprehensive Intervention and Outcome Research Programs for Acute Coronary Syndrome
To describe the role of genetic factors and its relationship and interaction with environmental factors in the recurrence of cardiac events in Chinese patients with acute coronary syndrome.
Read the detailed description
- Research cohort: Patients diagnosed with acute coronary syndrome are enrolled and to be followed up for 2 years.
- Baseline and follow up variables include patients' demographics, medical history, ACS event characteristics, clinical treatment options (interventional cardiology, drug therapy: antithrombotic therapy, other treatments recommended by guidelines ) and follow up events information.
- Blood Sample collection 4ml of vein blood will be drawed. Centrifugation of plasma and WBC will be done on-site within 30 minutes for DNA extraction. Samples will be stored at -80℃ freezer for subsequent applications.
- A nested case-controlled study is designed for the genetic analysis:
- Cases: Patients suffered from death, myocardial infarction, stroke and coronary revascularization and bleeding during the 2-year follow up. We expected to get 600 cases in the study cohort;
- Controls: among patients without any of the above events during follow, matched controls of 1:1 ratio will be selected according to date of admission (± 1 month), age (± 5 years), sex, baseline ACS diagnosis, whether treated with PCI , the same pattern of antithrombotic therapy and the study center.
- Genotyping Genotype testing using exome DNA chips (Exome Beadchip). Exome Beadchip is a high-throughput DNA chip designed by Illumina's, containing 240,000 SNP on exons in the genome that may lead to functional changes.
- Analysis:
- To analysis the impact of genetic characteristics on selection of treatment strategy in ACS patients, and its interaction with other baseline clinical variables.
- To analysis the impact of genetic characteristics on patient outcomes, and its interaction with clinical characteristics and management patterns.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, treatment strategy, genetics
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACS cohort | Patients diagnosed with acute coronary syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Death, Myocardial infarction, stroke, coronary revascularization
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964313
- Sponsor's protocol ID
- 2011BAI11B06
- Status last verified
- Jun 2016
- First submitted
- 14 Oct 2013
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Intervention and Outcome Research Programs for Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01964313
- Acronym / sponsor ID
- 2011BAI11B06
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, treatment strategy, genetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,422 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the role of genetic factors and its relationship and interaction with environmental factors in the recurrence of cardiac events in Chinese patients with acute coronary syndrome.
Detailed description
- Research cohort: Patients diagnosed with acute coronary syndrome are enrolled and to be followed up for 2 years.
- Baseline and follow up variables include patients' demographics, medical history, ACS event characteristics, clinical treatment options (interventional cardiology, drug therapy: antithrombotic therapy, other treatments recommended by guidelines ) and follow up events information.
- Blood Sample collection 4ml of vein blood will be drawed. Centrifugation of plasma and WBC will be done on-site within 30 minutes for DNA extraction. Samples will be stored at -80℃ freezer for subsequent applications.
- A nested case-controlled study is designed for the genetic analysis:
- Cases: Patients suffered from death, myocardial infarction, stroke and coronary revascularization and bleeding during the 2-year follow up. We expected to get 600 cases in the study cohort;
- Controls: among patients without any of the above events during follow, matched controls of 1:1 ratio will be selected according to date of admission (± 1 month), age (± 5 years), sex, baseline ACS diagnosis, whether treated with PCI , the same pattern of antithrombotic therapy and the study center.
- Genotyping Genotype testing using exome DNA chips (Exome Beadchip). Exome Beadchip is a high-throughput DNA chip designed by Illumina's, containing 240,000 SNP on exons in the genome that may lead to functional changes.
- Analysis:
- To analysis the impact of genetic characteristics on selection of treatment strategy in ACS patients, and its interaction with other baseline clinical variables.
- To analysis the impact of genetic characteristics on patient outcomes, and its interaction with clinical characteristics and management patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS cohort | – | –Patients diagnosed with acute coronary syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 75 hospitals in China.
Key inclusion criteria (18 listed)
- Written informed consent has been provided.
- Contact Order Form has been provided.
- Aged 18 years or older.
- Diagnosis of STEMI, NSTEMI or UA using the following definitions:
- Hospitalized within 48 hours of onset of symptoms.
Key exclusion criteria (6 listed)
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
- UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
- Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events
Time frame: 2 year
Death, Myocardial infarction, stroke, coronary revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Jiang, MD (8610-83575180, jiangjie@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016; AzTrials last refreshed its copy on 3 Nov 2026.