Prognostic Value of Lactate Levels in Patients With STEMI Undergoing Primary PCI

STEMI Clinical Trial

Official title:

Prognostic Value of Systemic Arterial Lactate Levels in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05503329
• Other study ID #: FWA000017585
• Status: Completed
• Start date: January 25, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Ahmed Maher Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 1. Careful history taking 2. Full cardiac examination 3. Investigations include: 1. 12 lead surface ECG. 2. Lactate level and full labs 3. Pre-discharge echocardiography 4. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with ST-segment elevation myocardial infarction for the first time.
• Patients undergoing primary PCI.
• Adult patients = 18 years old.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• ST Elevation Myocardial Infarction
• STEMI

Intervention

Diagnostic Test:
• arterial lactate level
an arterial lactate level measured from arterial sample from STEMI patients

Locations

Country	Name	City	State
Egypt	Ahmed Maher teaching hospiral	Cairo	Elsayda Zainab Square

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Maher Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse caediac events	we follow up occurrence of death, reinfarction, repeated hospitalization and new onset heart failure	30 days