Clinical trial NCT02131103: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Keywords: Pharmacoinvasive strategy
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: composite outcomes(included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amphoe Muang Chiang Mai
country: Thailand
facility: Chiang Mai University
state: Chiang Mai
Study officials:
References:
citation: Chotechuang Y, Phrommintikul A, Kuanprasert S, Muenpa R, Patumanond J, Chaichuen T, Sukonthasarn A. Cardiovascular outcomes of early versus delayed coronary intervention in low to intermediate-risk patients with STEMI in Thailand: a randomised trial. Heart Asia. 2019 Jun 12;11(2):e011201. doi: 10.1136/heartasia-2019-011201. eCollection 2019.