Clinical Presentations Before AMI Onset and Coronary Atherosclerosis

Acute Myocardial Infarction Clinical Trial

Official title:

Pre-infarction Angina and Culprit Plaque Characteristics in Patients With STEMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107624
• Other study ID #: HMUOCT-PIA
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: June 1, 2017

Study information

• Verified date: May 2018
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Men or non-pregnant women >18 years of age and < 85 years of age;

2. Patients undergo cardiac catheterization for AMI;

3. Patients able to provide written informed consent.

Exclusion Criteria:

1. Patients cant afford medical history;

2. Cardiac shock;

3. Severe left ventricular dysfunction;

4. Left main disease;

5. Hepatic or kidney dysfunction;

6. OCT was performed after predilation;

7. Poor OCT image or massive thrombus.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Secondary	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.	baseline