To quantify the effect of excimer laser angioplasty in patients with acute heart attack for salvaging the cardiac muscle.

JRCT ID: jRCTs032180107

Registered date:05/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: ST elevated anterior myocardial infarction
• Date of first enrollment: 25/07/2018
• Target sample size: 250
• Countries of recruitment: none other than Japan,Japan
• Study type: Interventional
• Intervention(s): Excimer laser coronary angioplasty is randomized for treatment followed by the placement of a biodegradable-polymer platinum chromium everolimus-eluting stent

Outcome(s)

Primary Outcome

myocardial salvage
Myocardial salvage = Area at risk (Total metabolic deficit from 123I-BMIPP) - Infarct size (Total perfusion deficit from 99mTc-tetrofosmin at 6-months post MI)

Myocardial salvage Index
Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images.

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).

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

1.ejection fraction measured with 99mTc-tetrofosmin myocardial scintigraphy at 6-months post intervention
2.Myocardial salvage, infarct size, microvascular obstruction derived by cardiac magnetic resonance imaging
Myocardial salvage = Area at risk from T2 imaging - Infarct size from late gadolinium enhancement
3.Intra-stent volume measured by optical coherence tomography.
4. Critical endpoints such as major adverse cardiac and cereberovascular events at 6, 12, 36, 60-months post intervention.

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Ikari Yuji
• Source(s) of Monetary Support: DVx Inc.,Boston Scientific Japan K.K.,Nihon Medi-Physics Co.,Ltd.
• Secondary ID(s): UMIN000032954