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Clinical Trials

Topic   Cardiology
Title   Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Primary PCI for STEMI (COMPLETE)
Summary   Patients who have had a heart attack (STEMI) and are within 72 hours of a successful PCI to the culprit (the cause or the problem) lesion and who also have an additional 70% or greater blockage that is not related to the heart attack are eligible for this study. The study is looking at whether restoring blood flow to all blocked or narrowed arteries is better than only restoring blood flow to the artery that caused the heart attack.
Description  

STEMI is a particular type of heart attack that involves full thickness cardiac muscle damage due to a sudden or abrupt onset of interrupted blood supply to a part of the heart. This type of heart attack can be detected by ECG (electrocardiography) change, as an elevation of the “ST segment” of the ECG waveform. Percutaneous Coronary Intervention, (PCI) is a medical intervention for blocked coronary arteries or for patients who are suffering a heart attack. A small mesh tube, called a stent is placed to help increase the size of the narrowed or blocked arteries and to improve blood and oxygen flow to the heart. T

his study enrolls patients who have had a STEMI and who are within 72 hours of successful PCI to the offending lesion, and who also have one or more heart artery blockages that are narrowed by 70% or more and that did not cause the heart attack. Doctors are not sure whether opening the additional artery (or arteries) will help improve a patient’s chance of living longer or of avoiding a future heart attack. This study will compare opening all blocked or narrowed heart arteries and giving medication therapy to treating the non-culprit blocked/narrowed arteries only with medication.

Eligible patients are randomly assigned by an automated system to either complete revascularization (all blocked lesions opened) or culprit lesion only revascularization (only the heart attack causing lesion is opened). Both groups will also receive medication therapy. After discharge from the hospital, there will be follow-up contacts. At six-weeks, the follow-up will be via phone or clinic visit. Clinic visit follow up will then occur at six months, one year and annually for up to five years. Chest pain symptoms and quality of life will be assessed by questionnaire at the six month and at the five year/final follow-up visit.

IRB Number   14007
Inclusion/Notes   Patients who have had a heart attack (STEMI) and are within 72 hours of a successful PCI to the culprit (the cause or the problem) lesion and who also have one or more non-culprit arteries with at least 70% blockage may be eligible for this study.
Principal Name   Srihari Naidu, MD
Contact Name   Wendy Drewes, BSN, RN, CCRC, Dipti Patel, MSN, MPH
Email   wdrewes@nyuwinthrop.org, dpatel@nyuwinthrop.org
Phone   516-663-2929
Alternate Phone   516-663-8692