SPECTACL: SPECTroscopic Assessment of Coronary Lipid

Completed · Phase 2/Phase 3

Conditions studied: Angina Pectoris, Angina, Unstable, Myocardial Infarction

In brief

The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI).

Key facts

Study ID

NCT00330928

Run by

Infraredx

People needed

106

Starts

2006-01-01

Expected to finish

2008-10-01

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion
• Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.
• Target lesion should have "low-risk" characteristics(defined by angiography)
• Subject must be able to read, understand and sign an approved informed consent form and follow protocol
• Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment

You may not qualify if…

• Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)
• Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.
• A contraindication to anticoagulation or increased risk of bleeding.
• Clinically significant abnormal laboratory findings
• Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS
• Elective PCI on or through bypass grafts or LIMA grafts
• Allergy or intolerance to aspirin or clopidogrel
• Planned use of laser ablation, rotational ablation, brachytherapy, or atherectomy device
• Enrollment or participation in any other medication trial within the previous 30 days
• Current enrollment participation or enrolled in another clinical trial
• Any other factor that the investigator feels would put the patient at increased risk if participating in the protocol

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• Duke Medical Center — Durham, North Carolina, United States
• Montreal Heart Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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