Myocardial InfarctionNCT06486233
Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.
An observational study of Myocardial Infarction, run by Gia Dinh People Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 385 participants
- Where
- 1 siteVietnam
- Study dates
- 22 Feb 2024to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Acute coronary syndrome due to stent thrombosis, or coronary artery bypass graft occlusion.
- Incomplete medical records.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Gia Dinh people hospital
Ho Chi Minh City
Sang Thanh Nguyen, 35, 0902489252, drsangthanhnguyen@gmail.com
About this study
Official title: Comparison of Mortality and Complication Rates (Re-myocardial Infarction, Heart Failure, Re-hospitalization, Stroke) After 12 Months Between Two Groups of Patients Undergoing Early Invasive and Late Invasive Strategies in Patients With Elderly Patients With High - Risk Non-ST-segment Elevation Acute Coronary Syndrome.
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?
- Conditions
- Myocardial Infarction
- Keywords
- percutaneous coronary intervention, elderly, non-ST-segment Elevation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital death
recorded when death occurs during treatment or is confirmed by in-hospital monitoring
Measured: one month
Secondary outcomes (2)
after 12 months death
determined by the patient follow-up period from hospital discharge until results were recorded
Measured: one year
MACE after 12 months include re-admission, recurrent myocardial infarction , stroke, heart failure
recorded
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start22 Feb 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486233
- Sponsor's protocol ID
- 329/HDDD-DHYD
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mortality and Complication Rates (Re-myocardial Infarction, Heart Failure, Re-hospitalization, Stroke) After 12 Months Between Two Groups of Patients Undergoing Early Invasive and Late Invasive Strategies in Patients With Elderly Patients With High - Risk Non-ST-segment Elevation Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT06486233
- Acronym / sponsor ID
- 329/HDDD-DHYD
- Conditions
- Myocardial Infarction
- Keywords
- percutaneous coronary intervention, elderly, non-ST-segment Elevation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Acute coronary syndrome due to stent thrombosis, or coronary artery bypass graft occlusion.
- Incomplete medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital death
Time frame: one month
recorded when death occurs during treatment or is confirmed by in-hospital monitoring
2 secondary outcomes
after 12 months death
Time frame: one year
MACE after 12 months include re-admission, recurrent myocardial infarction , stroke, heart failure
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Gia Dinh People Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang Thanh Nguyen, Doctor (+84902489252, drsangthanhnguyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital death (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.