NCT06486233

Brief Summary

The goal of this is observational study is to compare about MACE events and predisposing factors related to MACE events in elderly patients with high-risk non-ST acute coronary syndromes receiving early versus late invasive treatment . This study will anwser two questions. Question 1: What will factors associate with implementing a late invasive strategy in elderly patients with high-risk non-ST-segment elevation acute coronary syndrome ? Question 2: Is a meaningful difference about mortality and complication rates as re-myocardial infarction, heart failure, re-hospitalization, stroke after 12 months between two groups of patients undergoing early invasive and late invasive strategies in elderly patients with in high-risk non-ST-segment elevation acute coronary syndrome?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Feb 2024

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Progress55%
Feb 2024Mar 2028

Study Start

First participant enrolled

February 22, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Expected
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

June 12, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

percutaneous coronary intervention, elderly, non-ST-segment Elevation

Outcome Measures

Primary Outcomes (1)

  • In-hospital death

    recorded when death occurs during treatment or is confirmed by in-hospital monitoring

    one month

Secondary Outcomes (2)

  • after 12 months death

    one year

  • MACE after 12 months include re-admission, recurrent myocardial infarction , stroke, heart failure

    one year

Study Arms (2)

Observe the patient with early percutaneous coronary intervention

Elderly patients with non-ST-segment elevation acute coronary syndrome receive early percutaneous coronary intervention (\< 24 hours after diagnosis).

Observe the patient with late percutaneous coronary intervention

Elderly patients with non-ST elevation acute coronary syndrome undergoing late percutaneous coronary intervention (≥ 24 hours after diagnosis)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients aged 60 years and older were diagnosed with non-ST elevation acute coronary syndrome. Diagnosed with high-risk acute non-ST elevation syndrome and treated at Gia Dinh People's Hospital, Thong Nhat Hospital during the study period.

You may qualify if:

  • aged 60 years and older
  • high - risk non-ST-segment elevation acute coronary syndrome (according to the 2023 European Heart Association recommended standards).
  • receives reperfusion intervention.

You may not qualify if:

  • Acute coronary syndrome due to stent thrombosis, or coronary artery bypass graft occlusion.
  • Incomplete medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gia Dinh people hospital

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Sang Thanh Nguyen, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2024

First Posted

July 3, 2024

Study Start

February 22, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2028

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations