Health Condition 1: I248- Other forms of acute ischemic heart disease Health Condition 2: null- young indian acute coronary syndrome patients who are less than 45 years of age
Conditions
Interventions
None listed
Sponsors
Batra Hospital and Medical Research Centre
Abott Vascular
Eligibility
Inclusion criteria
Inclusion criteria: Patient is more than or equals to 18 and less than or equals to 45 years of age and going for PCI of the culprit lesion (more than 90 per cent diameter stenosis) At least more than or equals to 1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between more than or equals to 40 per cent and less than 90 per cent Patient has documented ACS ( unstable angina, NSTEMI or STEMI within the previous 72 hours) Patient demonstrates a left ventricular ejection fraction (LVEF) of more than or equals to 40 per cent as measured prior to enrollment Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect
Exclusion criteria
Exclusion criteria: The patient has a life expectancy of less than 24 months due to another medical condition Patient exhibits cardiogenic shock (systolic pressure less than 80mm Hg and PCWP more than 20mm Hg or cardiac index less than 1.8 liters per minute per meter square or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure more than 80 mm Hg) for any time within 24 hours prior to index procedure. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine more than 2.0 mg per dl or 177 µmol per l) Planned cardiac surgery procedure less than or equals to 6 months post-index procedure. Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months Patient has contraindication to Aspirin clopidogrel, prasugrel or ticagrelor Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 6 months post index procedure Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation Patient in whom the primary culprit lesion requiring PCI have one of the following characteristics – vessel is moderately or severely calcified, by visual estimate lesion is ostial in location (within 5.0 mm of vessel origin) lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a more than 60 degree bend in the vessel. lesion involves a diseased (more than 50 per cent stenotic) side branch more than 2.0 mm in diameter lesion is located in the left main coronary artery, whether protected or unprotected arterial or saphenous vein graft lesions or lesions distal to a diseased arterial or saphenous vein graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| minimum lumen area, fibrous cap thickness, lipid arc extension, presence of micro-calcification macrophage infiltration and microchannel formation at the explored plaques, spotty calcification and cholesterol crystals plaque disruption Intraluminal abnormalities: Red thrombus, White thrombus, Re-canalized thrombus In the group of stented patients additionally we will look for features of stent mal-apposition, NIH, plaque prolapse and intimal dissection Timepoint: baseline and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of MACE, a composite of Cardiac Death, MI or re-hospitalization for progressive anginaTimepoint: 30 days, 6, months and 1, 2 and 3 years | — |
Countries
India
Contacts
Public ContactYumnam Diana Devi
Batra Hospital & Medical Research Centre
Outcome results
None listed