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Circulating PRCP in STEMI Patients Undergoing Primary PCI

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ClinicalTrials.gov Identifier: NCT02772133
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Pan-Pan Hao, Qilu Hospital of Shandong University

Brief Summary:
Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on circulating prolylcarboxypeptidase (PRCP) level and activity.

Condition or disease Intervention/treatment
Myocardial Infarction Percutaneous Coronary Intervention PRCP Procedure: Primary PCI

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Study Type : Observational
Actual Enrollment : 275 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Study Start Date : May 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Group/Cohort Intervention/treatment
STEMI patients Procedure: Primary PCI
Healthy subjects
Unstable angina



Primary Outcome Measures :
  1. Circulating PRCP level [ Time Frame: 1 month ]
  2. Circulating PRCP activity [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Circulating Ang II level [ Time Frame: 1 month ]
  2. Circulating Ang-(1-7) level [ Time Frame: 1 month ]
  3. Circulating BK-(1-9) level [ Time Frame: 1 month ]
  4. Circulating KBK-(1-9) level [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI
Criteria

Inclusion Criteria:

  • Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
  • Age ≥18 years;
  • Informed consent from subject or next of kin.

Exclusion Criteria:

  • Nonischaemic Cardiomyopathy;
  • Cardiac surgery planed in the 6 months;
  • Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
  • Renal or hepatic failure;
  • Malignancy, HIV, or central nervous system disorder;
  • Cardiopulmonary resuscitation >15 min and compromised level of consciousness;
  • Cardiogenic shock;
  • Current participation in any research study involving investigational drugs or devices;
  • No written consensus;
  • Previous myocardial infarction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772133


Locations
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China, Shandong
Qianfoshan Hospital, Shandong University
Jinan, Shandong, China, 250012
Shandong University Qilu Hospital
Jinan, Shandong, China, 250012
Jinan Central Hospital, Shandong University
Jinan, Shandong, China, 250013
Shandong Provincial Hospital, Shandong University
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Qilu Hospital of Shandong University
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Responsible Party: Pan-Pan Hao, MD, PhD, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02772133    
Other Study ID Numbers: 2015GSF118133
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases