NCT02772133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

May 9, 2016

Last Update Submit

December 31, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Circulating PRCP level

    1 month

  • Circulating PRCP activity

    1 month

Secondary Outcomes (4)

  • Circulating Ang II level

    1 month

  • Circulating Ang-(1-7) level

    1 month

  • Circulating BK-(1-9) level

    1 month

  • Circulating KBK-(1-9) level

    1 month

Study Arms (3)

STEMI patients

Procedure: Primary PCI

Healthy subjects

Unstable angina

Interventions

Primary PCIPROCEDURE
STEMI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Qianfoshan Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Shandong University Qilu Hospital

Jinan, Shandong, 250012, China

Location

Jinan Central Hospital, Shandong University

Jinan, Shandong, 250013, China

Location

Shandong Provincial Hospital, Shandong University

Jinan, Shandong, 250021, China

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations