NCT06586424

Brief Summary

This study aims to evaluate the prognostic value of the anion gap in predicting major adverse cardiovascular events among patients with ST-segment elevation myocardial infarction. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as ST-segment elevation myocardial infarction and underwent primary percutaneous coronary intervention. The data consist of demographic data, clinical presentation, laboratory, and angiography result were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

August 31, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

anion gapmajor adverse cardiovascular eventsst-segment elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events (MACE)

    During hospitalization, up to 1 weeks

Secondary Outcomes (6)

  • Incidence of mortality

    During hospitalization, up to 1 weeks

  • Incidence of reinfarction

    During hospitalization, up to 1 weeks

  • Incidence of stroke

    During hospitalization, up to 1 weeks

  • Incidence of lethal arrhythmia

    During hospitalization, up to 1 weeks

  • Incidence of acute lung oedema

    During hospitalization, up to 1 weeks

  • +1 more secondary outcomes

Study Arms (1)

MACE group

Patient with STEMI who suffered major adverse cardiovascular events (MACE) after underwent primary percutaneous coronary intervention (PPCI)

Diagnostic Test: Anion gap

Interventions

Anion gapDIAGNOSTIC_TEST

Patient was taken blood examination before PPCI

MACE group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with ST-segment elevation myocardial infarction who underwent PPCI

You may qualify if:

  • Adults with 18 - 70 years old with diagnosis of STEMI who underwent PPCI

You may not qualify if:

  • History of heart failure due to any causes
  • Cardiogenic shock before PPCI
  • Any infection at the time of presentation
  • Pregnant woman
  • Other causes of high anion gap levels such as chronic kidney disease, metabolic acidosis, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Acid-Base Equilibrium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biochemical PhenomenaChemical PhenomenaHydrogen-Ion ConcentrationMetabolismHomeostasisPhysiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Leo Deddy Pradipta

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro

Study Record Dates

First Submitted

August 31, 2024

First Posted

September 19, 2024

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

October 5, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations