Acute Myocardial InfarctionNCT03107624
Clinical Presentations Before AMI Onset and Coronary Atherosclerosis
An observational study of Acute Myocardial Infarction, run by Harbin Medical University at 1 site in China.
Trial summary
This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test the hypothesis that different clinical presentations before AMI onset can affect coronary plaque morphologies in AMI patients . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 305 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 1 Jun 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AMI patients
Who may be able to join
- Men or non-pregnant women >18 years of age and < 85 years of age;
- Patients undergo cardiac catheterization for AMI;
- Patients able to provide written informed consent.
Who cannot join
- Patients cant afford medical history;
- Cardiac shock；
- Severe left ventricular dysfunction;
- Left main disease;
- Hepatic or kidney dysfunction;
- OCT was performed after predilation;
- Poor OCT image or massive thrombus.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
About this study
Official title: Pre-infarction Angina and Culprit Plaque Characteristics in Patients With STEMI
This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test the hypothesis that different clinical presentations before AMI onset can affect coronary plaque morphologies in AMI patients .
Read the detailed description
Patients with AMI who underwent primary percutaneous coronary intervention（PCI） and optical coherence tomography (OCT) examination is expected to be included in this study.Data about history were prospectively collected by a standard questionaire ,especially regarding the detail information about preinfarction angina.The basic clinical characteristics,angiographic and OCT findings are compared between patients with and without preinfarction angina.
- Conditions
- Acute Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in culprit lesion morphologies assessed by OCT according to the presence or absence of PIA
Plaque rupture was defined by the presence of a cavity formation in the plaque with a discontinuity of the fibrous cap. TCFA was defined as a lipid-rich plaque with a thin fibrous cap thickness of ≤ 65 um.Thrombus was identified by OCT as an irregular mass ≧0.25 mm in diameter protruding into the vessel lumen or attached to the surface of the vessel wall.Culprit lesion features in patients with PIA show a lower incidence of plaque rupture and TCFA compared to those without PIA.
Measured: baseline
Secondary outcomes (1)
In-hospital outcomes after AMI.
Infarct size was measured as the peak cardiac troponin I (cTnI) level.PIA is associated with lower infarct size and lower in-hospital mortality.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Jun 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, MD,PhD, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107624
- Sponsor's protocol ID
- HMUOCT-PIA
- Status last verified
- May 2018
- First submitted
- 22 Mar 2017
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-infarction Angina and Culprit Plaque Characteristics in Patients With STEMI
- ClinicalTrials.gov ID
- NCT03107624
- Acronym / sponsor ID
- HMUOCT-PIA
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test the hypothesis that different clinical presentations before AMI onset can affect coronary plaque morphologies in AMI patients .
Detailed description
Patients with AMI who underwent primary percutaneous coronary intervention（PCI） and optical coherence tomography (OCT) examination is expected to be included in this study.Data about history were prospectively collected by a standard questionaire ,especially regarding the detail information about preinfarction angina.The basic clinical characteristics,angiographic and OCT findings are compared between patients with and without preinfarction angina.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AMI patients
Key inclusion criteria (3 listed)
- Men or non-pregnant women >18 years of age and < 85 years of age;
- Patients undergo cardiac catheterization for AMI;
- Patients able to provide written informed consent.
Key exclusion criteria (7 listed)
- Patients cant afford medical history;
- Cardiac shock；
- Severe left ventricular dysfunction;
- Left main disease;
- Hepatic or kidney dysfunction;
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
Difference in culprit lesion morphologies assessed by OCT according to the presence or absence of PIA
Time frame: baseline
Plaque rupture was defined by the presence of a cavity formation in the plaque with a discontinuity of the fibrous cap. TCFA was defined as a lipid-rich plaque with a thin fibrous cap thickness of ≤ 65 um.Thrombus was identified by OCT as an irregular mass ≧0.25 mm in diameter protruding into the vessel lumen or attached to the surface of the vessel wall.Culprit lesion features in patients with PIA show a lower incidence of plaque rupture and TCFA compared to those without PIA.
1 secondary outcome
In-hospital outcomes after AMI.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Bo Yu, MD,PhD principal investigator
The Second Affiliated Hospital of Harbin Medical University
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 Myocardial Infarction, run by Harbin Medical University 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in culprit lesion morphologies assessed by OCT according to the presence or absence of PIA (time frame: baseline). 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 2 Dec 2019.