Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-04 @ 2:07 PM
Study NCT ID:
NCT02131103
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Short- and Long Term Outcomes of Early Routine PCI With the Standard Treatment in Low-intermediate Risk ST-elevation Myocardial Infarction Patients Who Successfully Fibrinolysis.
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
The Short- and Long Term Outcomes of Early Routine PCI With the Standard Treatment in Low-intermediate Risk ST-elevation Myocardial Infarction Patients Who Successfully Fibrinolysis.
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1. Objective: To evaluate short- and long-term in the STEMI patients who successfully thrombolysis with early routine and delay percutaneous coronary intervention in low-intermediate risk patients.
2. Educational/ application advantages: To evaluate the time of early and delay PCI after received fibrinolysis had an effect to the short- and long-term clinical outcomes in low- intermediate GRACE risk score patients. No available of randomized controlled study in these group of the patients.
2. Educational/ application advantages: To evaluate the time of early and delay PCI after received fibrinolysis had an effect to the short- and long-term clinical outcomes in low- intermediate GRACE risk score patients. No available of randomized controlled study in these group of the patients.
Detailed Description:
1.Research design: Intervention trial 1.1 Study domain: STEMI patients who will receive the fibrinolysis for reperfusion therapy 1.2 Target population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.3 Study population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital
Inclusion criteria:
1. The patients who received the percutaneous coronary intervention after fibrinolysis
2. Adult patients with age more than 18 years old
3. GRACE risk score less than 155 (low-intermediate risk)
Exclusion criteria:
1. The patients who received primary PCI or rescue PCI
2. The patients who had the previous history of coronary-artery bypass surgery
3. The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
1.4 Occurrence relation Y (Composite outcomes) = f (Treatment early vs. delay \| confounders)
1.5 Setting: The study will be conducted in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.6 Determinant (x): Time to percutaneous coronary intervention (early vs. delayed).
1.7 Events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
1.3 Study population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital
Inclusion criteria:
1. The patients who received the percutaneous coronary intervention after fibrinolysis
2. Adult patients with age more than 18 years old
3. GRACE risk score less than 155 (low-intermediate risk)
Exclusion criteria:
1. The patients who received primary PCI or rescue PCI
2. The patients who had the previous history of coronary-artery bypass surgery
3. The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
1.4 Occurrence relation Y (Composite outcomes) = f (Treatment early vs. delay \| confounders)
1.5 Setting: The study will be conducted in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.6 Determinant (x): Time to percutaneous coronary intervention (early vs. delayed).
1.7 Events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: