Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque (LUNAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
Simon Dixon, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01747525
First received: December 7, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

The primary objective of this study is to characterize coronary artery blockages as determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.


Condition Intervention
Coronary Artery Disease
Atherosclerosis
Device: NIRS/IVUS of coronary artery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Lipiscan and Ultrasound Interrogation of Atherosclerotic Coronary Arteries (LUNAR)

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque [ Time Frame: October, 2012 - October, 2013 ] [ Designated as safety issue: No ]
    The primary objective of this study is to characterize coronary artery blockages as determined by the Lipiscan combined NIRS-IVUS catheter in multiple coronary arteries.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NIRS/IVUS of coronary artery
All patients will have an epicardial coronary artery stenosis of intermediate severity (>50% to <70% stenosis) (stenosis ≥20% - ≤70%) by invasive angiography in whom IVUS is planned to further clinical evaluation of lesion severity; or a severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment.
Device: NIRS/IVUS of coronary artery
Evaluation of coronary plaque by NIRS/IVUS.
Other Name: Infraredx

Detailed Description:

This is a prospective, observational, single-center registry that will enroll 100 patients. All patients presenting to Beaumont Hospital for elective invasive coronary angiography and possible ad hoc percutaneous coronary intervention balloon angioplasty will be considered for inclusion. Patients must meet all inclusion and exclusion criteria prior to consent. All information requested as part of this study will be obtained from clinical data as part of each subject's standard medical care. Cardiac catheterization and percutaneous coronary intervention will be performed according to standard guidelines and clinical practice. All aspects of clinical care of the patient will follow routine standards as determined by institutional policies, published clinical practice guidelines, and the treating physician.

After completion of routine invasive coronary angiography and upon determining that the patient has either (1) an epicardial de novo coronary artery lesion of indeterminate severity (>50% to <70% stenosis) that requires IVUS analysis for further delineation of stenosis (blockage) severity; or (2) a severe epicardial de novo coronary artery lesion that requires PCI for definitive treatment, combined NIR-IVUS imaging will be carried out in the target-vessel. Upon completion of NIRS-IVUS imaging of the target-vessel, percutaneous intervention will be performed in the standard fashion if deemed clinically appropriate. Upon completion of target-vessel intervention, NIRS-IVUS imaging will then be repeated in the target-vessel.

Upon completion of the treatment of the target-vessel, NIRS-IVUS will be performed in any other major epicardial vessel containing a stenosis ≥30% if deemed appropriate by the treating cardiologist.

Patients will be carefully monitored throughout their hospital stay and will be followed either by office visit or by telephone at 6 months (± 7 days); 12 months (± 14 days); 24 months (± 30 days); 36 months (± 30 days); 48 months (± 30 days); and 60 months (± 30 days).

The patient's medical records will be accessed to collect data about medical history and activities during the course of the study. All data will be collected by using standard case report forms. Follow up data after discharge will be collected using a phone script questionnaire . All data forms will include unique study identifiers to protect the participants personal identity. All data will be recorded in an Excel spreadsheet and kept on a secure computer requiring password entry.

There are no additional required medical procedures as part of this protocol beyond the use of the NIRS-IVUS catheter during the index procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients presenting to Beaumont Hospital for elective invasive coronary angioplasty and possible percutaneous intervention.

Criteria

Inclusion Criteria:

(1) Subject is at least 18 years of age; (2) Subject is scheduled for elective, clinically-indicated, invasive coronary angiography; (3) Subject is willing and able to provide informed written consent prior to invasive angiography; (4) Combined NIRS-IVUS is not contra-indicated per the cardiologist performing invasive coronary angiography; and (5) Patient has either: (a) An epicardial coronary artery stenosis of intermediate severity (>50% to <70% stenosis)by invasive angiography in whom IVUS is planned to further evaluate lesion severity; or (b) A severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment.

Exclusion Criteria:

(1) Subject life expectancy at time of invasive angiography is less than 2 years; (2) Subject is pregnant or suspected to be pregnant; (3) Subject is unable to provide informed consent; (4) Any factor deemed by the treating cardiologist to put the patient at increased risk of participating in the protocol (i.e. coronary artery anatomy is not suitable for traditional IVUS secondary to severe tortuousity or excessive calcification). (5) Bacteremia or sepsis, (6) Major coagulation system abnormalities, (7) Severe hemodynamic instability or shock, (8) Patients diagnosed with coronary artery spasm, ((9) Patients disqualified for CABG surgery, (109) Total occlusion, (11) Patients disqualified for PTCA, (12) Patients who are not suitable for IVUS procedures.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747525

Contacts
Contact: James L Smith, MD 248-898-4183 james.smith@beaumont.edu

Locations
United States, Michigan
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Mark Pica, BS    248-898-5590    mpica@beaumont.edu   
Principal Investigator: Simon R Dixon, MBChB         
Sponsors and Collaborators
Simon Dixon, MD
Investigators
Principal Investigator: Simon R Dixon, MBChB William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Simon Dixon, MD, Chair, Department of Cardiovascular Medicine, Co-Director of Cardiovascular Research, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01747525     History of Changes
Other Study ID Numbers: 2011-258
Study First Received: December 7, 2012
Last Updated: December 7, 2012
Health Authority: United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014