NCT05503329

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 14, 2022

Last Update Submit

August 16, 2022

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

  • Major adverse caediac events

    we follow up occurrence of death, reinfarction, repeated hospitalization and new onset heart failure

    30 days

Interventions

arterial lactate levelDIAGNOSTIC_TEST

an arterial lactate level measured from arterial sample from STEMI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

STEMI patients treated with primary PCI

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maher teaching hospiral

Cairo, Elsayda Zainab Square, 11617, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 38127545DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical doctor

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 16, 2022

Study Start

January 25, 2022

Primary Completion

June 27, 2022

Study Completion

June 30, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)