To quantify the effect of excimer laser angioplasty in patients with acute heart attack for salvaging the cardiac muscle.
- Conditions
- ST elevated anterior myocardial infarctionSTEMI
- Registration Number
- JPRN-jRCTs032180107
- Lead Sponsor
- Ikari Yuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1. ST elevated anterior myocardial infarction within 6 hours of onset
2. Age of 21 or more at time of consent
3. The research patient has been thoroughly informed of the contents of the study, and written consent has been obtained from the subject or a legal guardian
1. The subject is in cardiogenic shock prior upon arrival.
2. The culprit coronary lesion is either the right, circumflex, or distal left anterior descending coronary artery.
3. TIMI grade 2 or 3 after initial coronary angiography.
4. A culprit lesion less than 2.5 mm in diameter.
5. A subject that is considered incapable of consent due to psychiatric or other causes.
6. A subject who is deemed inadequate by the principle/ sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method myocardial salvage<br>Myocardial salvage = Area at risk (Total metabolic deficit from 123I-BMIPP) - Infarct size (Total perfusion deficit from 99mTc-tetrofosmin at 6-months post MI)<br><br>Myocardial salvage Index<br>Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images.<br><br>The Myocardial salvage (17-segment) was calculated by subtracting the total sum of the 123I-BMIPP and 99mTc-tetrofosmin defect scores in each segment ((sigma sum)123I-BMIPP defect score minus 99mTc-(sigma sum)tetrofosmin defect score). <br><br>Myocardial Salvage index was calculated as follows: Myocardial Salvage index = (siguma sum)123I-BMIPP defect score minus (sigma sum)99mTc-tetrofosmin defect score/ (sigma sum)123I-BMIPP defect score x 100 (%).
- Secondary Outcome Measures
Name Time Method 1.ejection fraction measured with 99mTc-tetrofosmin myocardial scintigraphy at 6-months post intervention <br>2.Myocardial salvage, infarct size, microvascular obstruction derived by cardiac magnetic resonance imaging <br>Myocardial salvage = Area at risk from T2 imaging - Infarct size from late gadolinium enhancement<br>3.Intra-stent volume measured by optical coherence tomography. <br>4. Critical endpoints such as major adverse cardiac and cereberovascular events at 6, 12, 36, 60-months post intervention.