Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement Diabetics Presenting With Acute Coronary Syndrome (OFDI-DM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Aloke V. Finn, Emory University
ClinicalTrials.gov Identifier:
NCT01794949
First received: November 7, 2012
Last updated: May 27, 2014
Last verified: May 2014

November 7, 2012
May 27, 2014
September 2013
January 2016   (final data collection date for primary outcome measure)
Percent stent coverage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assessment of the frequency of vascular healing 6 months after RESOLUTE Integrity placement in patients with non-insulin dependent diabetes presenting with ACS using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI.
Same as current
Complete list of historical versions of study NCT01794949 on ClinicalTrials.gov Archive Site
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Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement Diabetics Presenting With Acute Coronary Syndrome
Optical Frequency Domain Imaging (OFDI) Determined Stent Strut Coverage and Plaque Morphology After RESOLUTE Stent Placement in Non-Insulin Dependent Diabetics Presenting With Acute Coronary Syndrome (ACS)

The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications such as clot formation on the stent which may lead to a heart attack. Diabetic patients and those presenting with a heart attack at the time of stent placement are at increased risk for clot formation the stent however little is known of the healing responses after stent placement in these populations.

Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners, thereby improving the long-term safety of DES.

Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both preclinical and clinical studies.

The purpose of this trial is to determine the healing responses to the RESOLUTE Intregrity stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically in this observational study, we will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement.

The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Non-insulin dependent diabetic and non- diabetic patients undergoing percutaneous transluminal cononary intervention (PTCI) for the treatment of acute coronary syndrome with a single drug eluting stent (DES).

Coronary Artery Disease
Device: Resolute Integrity stent
Drug eluting stents used to treat coronary artery blockages
  • Control
    Non-diabetic patients with percent covered struts measured at 6 months following Resolute stent placement
    Intervention: Device: Resolute Integrity stent
  • NIDDM
    Non-insulin dependent diabetes mellitus (NIDDM) patients with percent covered struts measured at 6 months following Resolute stent placement
    Intervention: Device: Resolute Integrity stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
July 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient requiring PTCI for acute coronary syndrome (ACS) and meeting criteria (as determined by the performing physician) for Resolute Integrity stent placement.

Exclusion Criteria:

  • ST segment elevation MI (STEMI)
  • stable angina
  • current or planned pregnancy (for women of childbearing age)
  • treatment of > 2 lesions during the index hospitalization
  • insulin dependent diabetic patients at the time of stent placement
  • use of overlapping stents.
Both
18 Years to 80 Years
No
Contact: Aloke V Finn, MD 404 686 2508 avfinn@emory.edu
Contact: Anwer K Habib, MD 404 727 8905 akhabib@emory.edu
United States
 
NCT01794949
IRB00057208
Yes
Aloke V. Finn, Emory University
Emory University
Not Provided
Principal Investigator: Aloke V Finn, MD Emory University
Emory University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP