Myocardial Infarction Clinical Trial
| NCT number | NCT02772133 |
| Other study ID # | 2015GSF118133 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2016 |
| Est. completion date | July 2016 |
| Verified date | December 2019 |
| Source | Qilu Hospital of Shandong University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 275 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Jinan Central Hospital, Shandong University | Jinan | Shandong |
| China | Qianfoshan Hospital, Shandong University | Jinan | Shandong |
| China | Shandong Provincial Hospital, Shandong University | Jinan | Shandong |
| China | Shandong University Qilu Hospital | Jinan | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| Qilu Hospital of Shandong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Circulating PRCP level | 1 month | ||
| Primary | Circulating PRCP activity | 1 month | ||
| Secondary | Circulating Ang II level | 1 month | ||
| Secondary | Circulating Ang-(1-7) level | 1 month | ||
| Secondary | Circulating BK-(1-9) level | 1 month | ||
| Secondary | Circulating KBK-(1-9) level | 1 month |
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