Myocardial InfarctionNCT02772133
Circulating PRCP in STEMI Patients Undergoing Primary PCI
An observational study of Myocardial Infarction and Percutaneous Coronary Intervention, run by Qilu Hospital of Shandong University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Percutaneous Coronary Intervention, PRCP
- What is being tested?
- Primary PCI
- Type of treatment
- Surgery or procedure
- How many people
- 275 participants
- Where
- 4 sitesChina
- Study dates
- May 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI
Who may be able to join
- 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.
Who cannot join
- 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;
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- Cardiogenic shock;
- Current participation in any research study involving investigational drugs or devices;
- No written consensus;
- Previous myocardial infarction.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Qianfoshan Hospital, Shandong University
Jinan, Shandong, 250012
Shandong University Qilu Hospital
Jinan, Shandong, 250012
Jinan Central Hospital, Shandong University
Jinan, Shandong, 250013
Shandong Provincial Hospital, Shandong University
Jinan, Shandong, 250021
About this study
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.
- Being tested
- Primary PCI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary PCIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | Not described Receives: Procedure: Primary PCI | |
| Healthy subjects | Not described | |
| Unstable angina | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating PRCP level
Measured: 1 month
Circulating PRCP activity
Measured: 1 month
Secondary outcomes (4)
Circulating Ang II level
Measured: 1 month
Circulating Ang-(1-7) level
Measured: 1 month
Circulating BK-(1-9) level
Measured: 1 month
Circulating KBK-(1-9) level
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772133
- Sponsor's protocol ID
- 2015GSF118133
- Status last verified
- Dec 2019
- First submitted
- 9 May 2016
- Last updated
- 3 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating PRCP in STEMI Patients Undergoing Primary PCI
- ClinicalTrials.gov ID
- NCT02772133
- Acronym / sponsor ID
- 2015GSF118133
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | – | Procedure: Primary PCI |
| Healthy subjects | – | – |
| Unstable angina | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary PCI | Procedure or surgery | STEMI patients |
Primary outcome
Circulating PRCP level
Time frame: 1 month
Circulating PRCP activity
Time frame: 1 month
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Percutaneous Coronary Intervention, run by Qilu Hospital of Shandong University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating PRCP level (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.