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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

Tracking Information
First Submitted Date May 9, 2016
First Posted Date May 13, 2016
Last Update Posted Date January 3, 2020
Study Start Date May 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2016)
  • Circulating PRCP level [ Time Frame: 1 month ]
  • Circulating PRCP activity [ Time Frame: 1 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 10, 2016)
  • Circulating Ang II level [ Time Frame: 1 month ]
  • Circulating Ang-(1-7) level [ Time Frame: 1 month ]
  • Circulating BK-(1-9) level [ Time Frame: 1 month ]
  • Circulating KBK-(1-9) level [ Time Frame: 1 month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Circulating PRCP in STEMI Patients Undergoing Primary PCI
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI
Condition
  • Myocardial Infarction
  • Percutaneous Coronary Intervention
  • PRCP
Intervention Procedure: Primary PCI
Study Groups/Cohorts
  • STEMI patients
    Intervention: Procedure: Primary PCI
  • Healthy subjects
  • Unstable angina
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 31, 2019)
275
Original Estimated Enrollment
 (submitted: May 10, 2016)
220
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02772133
Other Study ID Numbers 2015GSF118133
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pan-Pan Hao, Qilu Hospital of Shandong University
Study Sponsor Qilu Hospital of Shandong University
Collaborators Not Provided
Investigators Not Provided
PRS Account Qilu Hospital of Shandong University
Verification Date December 2019