Circulating PRCP in STEMI Patients Undergoing Primary PCI

December 31, 2019 updated by: Pan-Pan Hao, Qilu Hospital of Shandong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Shandong University Qilu Hospital
      • Jinan, Shandong, China, 250012
        • Qianfoshan Hospital, Shandong University
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital, Shandong University
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circulating PRCP level
Time Frame: 1 month
1 month
Circulating PRCP activity
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Circulating Ang II level
Time Frame: 1 month
1 month
Circulating Ang-(1-7) level
Time Frame: 1 month
1 month
Circulating BK-(1-9) level
Time Frame: 1 month
1 month
Circulating KBK-(1-9) level
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015GSF118133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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