STEMINCT05503329
Prognostic Value of Lactate Levels in Patients With STEMI Undergoing Primary PCI
An observational study of STEMI, run by Ahmed Maher Teaching Hospital at 1 site in Egypt.
Trial summary
To assess the prognostic value of systemic arterial lactate levels in patients with ST segment elevation myocardial infarction undergoing primary PCI and correlate with the results of primary PCI and 30 days MACE follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- What is being tested?
- arterial lactate level
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2022to 30 Jun 2022
- 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: STEMI patients treated with primary PCI
Who may be able to join
- Patient with ST-segment elevation myocardial infarction for the first time.
- Patients undergoing primary PCI.
- Adult patients ≥ 18 years old.
Who cannot join
- Hemodynamically unstable patients.
- Patients with renal impairment (creatinine clearance < 30 ml/min).
- Patients who developed flow limiting coronary dissection or mechanical complication during the procedure.
- Patients presenting > 24 hours after symptoms onset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Systemic Arterial Lactate Levels in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
To assess the prognostic value of systemic arterial lactate levels in patients with ST segment elevation myocardial infarction undergoing primary PCI and correlate with the results of primary PCI and 30 days MACE follow up.
Read the detailed description
- Study Population: STEMI patients treated with primary PCI.
- Study period: over 6 months.
- Sample Size: 300 patients.
All patients received the standard care for acute STEMI patients which is the primary percutaneous intervention in addition to medications.
Hyperlactemia is defined as elevated lactic acid level in the blood. The normal blood lactate level is (0.5-1 mmol/L).
All subjects were subjected to
- Careful history taking
- Full cardiac examination
- Investigations include:
- 12 lead surface ECG.
- Lactate level and full labs
- Pre-discharge echocardiography
- Peri-procedural details of primary PCI the investigators assessed the relation between hyperlactemia and coronary flow, peak cardiac enzymes, hemodynamic parameters and MACE in 30 days follow up
- Conditions
- STEMI
- Being tested
- arterial lactate level
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial lactate levelDiagnostic test
an arterial lactate level measured from arterial sample from STEMI patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse caediac events
we follow up occurrence of death, reinfarction, repeated hospitalization and new onset heart failure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start25 Jan 2022
- Primary completion27 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Maher Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Hamdy Abdelhasseeb, Ahmed Maher Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503329
- Sponsor's protocol ID
- FWA000017585
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Salam A, El-Sayed A, Abdel-Haseeb A, Ibrahim M. Prognostic value of arterial lactate index in ST-elevation myocardial infarction treated with primary percutaneous coronary intervention: a prospective cohort study. Future Cardiol. 2023 Dec;19(16):767-777. doi: 10.2217/fca-2023-0065. Epub 2023 Dec 21.
PubMed 38127545
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Systemic Arterial Lactate Levels in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT05503329
- Acronym / sponsor ID
- FWA000017585
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ahmed Maher Teaching HospitalOther government
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Aug 2022 (actual)
- 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.
To assess the prognostic value of systemic arterial lactate levels in patients with ST segment elevation myocardial infarction undergoing primary PCI and correlate with the results of primary PCI and 30 days MACE follow up.
Detailed description
- Study Population: STEMI patients treated with primary PCI.
- Study period: over 6 months.
- Sample Size: 300 patients.
All patients received the standard care for acute STEMI patients which is the primary percutaneous intervention in addition to medications.
Hyperlactemia is defined as elevated lactic acid level in the blood. The normal blood lactate level is (0.5-1 mmol/L).
All subjects were subjected to
- Careful history taking
- Full cardiac examination
- Investigations include:
- 12 lead surface ECG.
- Lactate level and full labs
- Pre-discharge echocardiography
- Peri-procedural details of primary PCI the investigators assessed the relation between hyperlactemia and coronary flow, peak cardiac enzymes, hemodynamic parameters and MACE in 30 days follow up
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients treated with primary PCI
Key inclusion criteria (3 listed)
- Patient with ST-segment elevation myocardial infarction for the first time.
- Patients undergoing primary PCI.
- Adult patients ≥ 18 years old.
Key exclusion criteria (4 listed)
- Hemodynamically unstable patients.
- Patients with renal impairment (creatinine clearance < 30 ml/min).
- Patients who developed flow limiting coronary dissection or mechanical complication during the procedure.
- Patients presenting > 24 hours after symptoms onset.
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 |
|---|---|---|
| arterial lactate levelan arterial lactate level measured from arterial sample from STEMI patients | Diagnostic test | – |
Primary outcome
Major adverse caediac events
Time frame: 30 days
we follow up occurrence of death, reinfarction, repeated hospitalization and new onset heart failure
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 18 Aug 2022.
- Derived from this study: PubMed 38127545Abdel-Salam A, El-Sayed A, Abdel-Haseeb A, Ibrahim M. Prognostic value of arterial lactate index in ST-elevation myocardial infarction treated with primary percutaneous coronary intervention: a prospective cohort study. Future Cardiol. 2023 Dec;19(16):767-777. doi: 10.2217/fca-2023-0065. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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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.
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 STEMI, run by Ahmed Maher Teaching Hospital at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 18 Aug 2022. 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 Egypt. 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?
Major adverse caediac events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503329, which also lists 1 linked publication.
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 18 Aug 2022.