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Near-infrared Spectroscopy Guided Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460482
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Manijeh Noori, Odense University Hospital

Brief Summary:
The aim of this study is to investigate whether near-infrared guided percutaneous coronary intervention in patients with acute myocardial infarction provides improved stent strut coverage at six months compared to conventionally angiography guided percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Myocardial Ischemia Atherosclerosis Lipid-Rich Atherosclerosis of Coronary Artery Vascular Diseases Infarct Ischemia Device: Near-infrared spectroscopy (NIRS) Device: Angiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients randomized to NIRS-guided or standard angiographic-guided intervention with DES
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Offline data analyzis are being performed without knowing which intervention group the patients are from
Primary Purpose: Treatment
Official Title: Near-infrared Spectroscopy Guided Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: NIRS-guided PCI
Near-infrared Spectroscopy guided Percutaneous coronary intervention with implantation of drug-eluting stent
Device: Near-infrared spectroscopy (NIRS)
NIRS-guided PCI

Active Comparator: Angiography-guided PCI
Angiography-guided percutaneous coronary intervention with implantation of a drug-eluting stent
Device: Angiography
Angiography guided PCI




Primary Outcome Measures :
  1. Proportion of stent strut coverage [ Time Frame: 6 months after index percutaneous coronary intervention ]
    Proportion of stent strut coverage at 6 months follow up estimated by OCT


Secondary Outcome Measures :
  1. Uncovered stent struts [ Time Frame: 6 months after index percutaneous coronary intervention ]
  2. Persistent stent malapposition [ Time Frame: 6 months after index percutaneous coronary intervention ]
  3. Maximal neointimal growth [ Time Frame: 6 months after index percutaneous coronary intervention ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute coronary syndrome (ST-elevation myocardial infarction and non-ST elevation myocardial infarction) referred for invasive coronary angiography and percutaneous coronary intervention at Department of Cardiology, Odense University Hospital (Odense, Denmark)

Exclusion Criteria:

  • participation in other randomized clinical trials
  • life expectancy < 1 year
  • allergy to aspirin, clopidogrel, ticagrelor or prasugrel
  • eGFR < 30 mL/min
  • tortuous and angiographically estimated extremely calcified lesions
  • ostial, left main and bifurcation lesions
  • lesions in a reference vessel diameter < 2.0 mm
  • hemodynamic instability
  • Scheduled for coronary artery bypass grafting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460482


Contacts
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Contact: Manijeh Noori, MD +45 42327909 mnoori2015@hotmail.com

Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Contact: Manijeh Noori, MD       mnoori2015@hotmail.com   
Principal Investigator: Lisette Okkels Jensen, MD DMSci PhD Prof         
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Chair: Lisette Okkels Jensen, MD PhD Prof Odense University Hospital
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Responsible Party: Manijeh Noori, MD; PhD-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04460482    
Other Study ID Numbers: s-20200010
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manijeh Noori, Odense University Hospital:
drug-eluting stent
near-infrared spectrocopy
intravascular ultrasound
optical coherence tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Vascular Diseases
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Myocardial Ischemia
Myocardial Infarction
Atherosclerosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis