Clinical Presentations Before AMI Onset and Coronary Atherosclerosis

NCT03107624 | Completed

• 1 other identifier: HMUOCT-PIA
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• In-hospital outcomes after AMI.

  baseline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AMI patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Study Officials

• Bo Yu, MD,PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology of The 2nd Affiliated Hospital of Harbin Medical University

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 2, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)