ST Elevatation Myocardial Infarction (STEMI)Prok-IdmNCT02021487
Prokinecitine in Acute Myocardial Infarction
An observational study of ST Elevatation Myocardial Infarction (STEMI), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevatation Myocardial Infarction (STEMI)
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute St elevation myocardial infarction of less than 6 hours
Who may be able to join
- Patients with acute St elevation myocardial infarction of less than 6 hours
- Age>18 y/o
Who cannot join
- Previous myocardial infarction
- LBB, RBB
- Renal Insuffiency MDRD<30 mL/min
- Patient with Pace-Maker or ICD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Prok-Idm: Interest of Dosage of Prokinecitine in Acute Myocardial Infarction
The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size by MRI necrotic myocardial mass
Infarct size by MRI necrotic myocardial mass
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2019
- Study completionFeb 2019
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevatation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick OHLMANN, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021487
- Sponsor's protocol ID
- 5515
- Acronym
- Prok-Idm
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2013
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Prok-Idm: Interest of Dosage of Prokinecitine in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02021487
- Acronym / sponsor ID
- Prok-Idm / 5515
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 27 Dec 2013 (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.
The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute St elevation myocardial infarction of less than 6 hours
Key inclusion criteria (2 listed)
- Patients with acute St elevation myocardial infarction of less than 6 hours
- Age>18 y/o
Key exclusion criteria (4 listed)
- Previous myocardial infarction
- LBB, RBB
- Renal Insuffiency MDRD<30 mL/min
- Patient with Pace-Maker or ICD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infarct size by MRI necrotic myocardial mass
Time frame: 7 days
Infarct size by MRI necrotic myocardial mass
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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.
Patrick OHLMANN, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevatation Myocardial Infarction (STEMI), run by University Hospital, Strasbourg, France at 1 site in France.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
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?
Infarct size by MRI necrotic myocardial mass (time frame: 7 days). 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 21 Aug 2019.