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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Resolute Integrity stent

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 76
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
Non-diabetic patients with percent covered struts measured at 6 months following Resolute stent placement
Device: Resolute Integrity stent
Drug eluting stents used to treat coronary artery blockages
NIDDM
Non-insulin dependent diabetes mellitus (NIDDM) patients with percent covered struts measured at 6 months following Resolute stent placement
Device: Resolute Integrity stent
Drug eluting stents used to treat coronary artery blockages

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

Criteria

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.
  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: NCT01794949

Contacts
Contact: Aloke V Finn, MD 404 686 2508 avfinn@emory.edu
Contact: Anwer K Habib, MD 404 727 8905 akhabib@emory.edu

Locations
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Teresa Sanders    404-686-3872    theresa.sanders@emoryhealthcare.org   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Aloke V Finn, MD Emory University
  More Information

Publications:
Responsible Party: Aloke V. Finn, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01794949     History of Changes
Other Study ID Numbers: IRB00057208
Study First Received: November 7, 2012
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014