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Completed

NCT Number: NCT03107624

Clinical Presentations Before AMI Onset and Coronary Atherosclerosis

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 .

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

：

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. In-hospital outcomes after AMI.

    Time frame: baseline

    Infarct size was measured as the peak cardiac troponin I (cTnI) level.PIA is associated with lower infarct size and lower in-hospital mortality.

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2017
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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