NCT03607201

Brief Summary

This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

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

August 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

July 23, 2018

Last Update Submit

October 13, 2018

Conditions

Keywords

acute coronary syndromediabetesheart failureacute pulmonary edemamalignant arrhythmia

Outcome Measures

Primary Outcomes (6)

  • Heart Failure

    Based on echocardiographic findings from the medical records

    Through study completion, an average of 1 year

  • Malignant Arrhythmia

    Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)

    Through study completion, an average of 1 year

  • Acute Lung Edema

    Based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation \<90%.

    Through study completion, an average of 1 year

  • Cardiogenic Shock

    Clinical Diagnosis of Cardiogenic Shock reported in medical records

    Through study completion, an average of 1 year

  • Recurrent Myocardial Infarction

    Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

    Through study completion, an average of 1 year

  • Mortality

    Patient death reported in medical records

    Through study completion, an average of 1 year

Other Outcomes (2)

  • GRACE Score

    Through study completion, an average of 1 year

  • TIMI Score

    Through study completion, an average of 1 year

Study Arms (2)

Diabetic

History of diabetes prior to Acute Coronary Syndrome

Other: No intervention

Non-diabetic

No documented history of diabetes prior to Acute Coronary Syndrome

Other: No intervention

Interventions

Routine care

DiabeticNon-diabetic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9.

You may qualify if:

  • Clinical diagnosis of Acute Coronary Syndrome
  • Presence of detail on diabetes history

You may not qualify if:

  • Unavailability of electrocardiographic findings, cardiac marker results
  • Incomplete records of prior medical and treatment history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cengkareng General Hospital

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Acute Coronary SyndromeDiabetes MellitusHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anthony P Sunjaya

    Tarumanagara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 31, 2018

Study Start

August 1, 2017

Primary Completion

June 30, 2018

Study Completion

August 31, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations