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

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.

Study Overview

• Status: Completed
• Conditions: STEMI
• Intervention / Treatment: Diagnostic test: arterial lactate level

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

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

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Egypt
  • Elsayda Zainab Square
    • Cairo, Elsayda Zainab Square, Egypt, 11617
      • Ahmed Maher teaching hospiral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

STEMI patients treated with primary PCI

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse caediac events	we follow up occurrence of death, reinfarction, repeated hospitalization and new onset heart failure	30 days

Collaborators and Investigators

• Sponsor: Ahmed Maher Teaching Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2022
• Primary Completion (ACTUAL): June 27, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: August 14, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (ACTUAL): August 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: FWA000017585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No