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Intravascular Ultrasound Guided PCI in STEMI (iSTEMI)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PCI + Ischemic conditioning
Stent with ultrasound
Sponsored by
Thomas Engstrom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Primary PCI, Coronary angiography, Intravascular ultra sound (IVUS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Acute onset of chest pain with <12 hours duration
  • STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.

Exclusion Criteria (iPOST2):

Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI > 12 hours Culprit in bypass graft Other reason for not including the patient

Exclusion Criteria (iSTEMI):

Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI > 12 hours Culprit in bypass graft Other reason

Sites / Locations

  • Heart Center, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

PCI standard

PCI standard + ischemic conditioning

Stent with ultrasound

Stent without ultrasound

Arm Description

Outcomes

Primary Outcome Measures

iPOST
Number of participants that experience all-cause mortality or hospitalization for heart failure
IVUS
Number of participants that experience all-cause mortality, target vessel revascularization and new myocardial infarction

Secondary Outcome Measures

Full Information

First Posted
February 17, 2021
Last Updated
January 18, 2023
Sponsor
Thomas Engstrom
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1. Study Identification

Unique Protocol Identification Number
NCT04775914
Brief Title
Intravascular Ultrasound Guided PCI in STEMI
Acronym
iSTEMI
Official Title
The STEMI Optimization Trial - Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 1, 2027 (Anticipated)
Study Completion Date
February 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Engstrom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of is study is to investigate whether intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
Primary PCI, Coronary angiography, Intravascular ultra sound (IVUS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial As a second randomization to the iPOST2 trial (ID: H-180512561,NCT03787745) patients are randomized 1:1 to either a) receiving ultrasound guidance before and after stent placement or b) no ultrasound, independently of randomization in the iPOST2 trial. The iPOST2 trial was initiated February 2019.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCI standard
Arm Type
Active Comparator
Arm Title
PCI standard + ischemic conditioning
Arm Type
Experimental
Arm Title
Stent with ultrasound
Arm Type
Experimental
Arm Title
Stent without ultrasound
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PCI + Ischemic conditioning
Intervention Description
IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
Intervention Type
Procedure
Intervention Name(s)
Stent with ultrasound
Intervention Description
IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.
Primary Outcome Measure Information:
Title
iPOST
Description
Number of participants that experience all-cause mortality or hospitalization for heart failure
Time Frame
Until expected number of events are adjudicated up til 3 years
Title
IVUS
Description
Number of participants that experience all-cause mortality, target vessel revascularization and new myocardial infarction
Time Frame
Until expected number of events are adjudicated up til 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Acute onset of chest pain with <12 hours duration STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI. Exclusion Criteria (iPOST2): Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI > 12 hours Culprit in bypass graft Other reason for not including the patient Exclusion Criteria (iSTEMI): Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI > 12 hours Culprit in bypass graft Other reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Engstrøm, MD PhD DSci
Phone
+45 3545 8444
Email
Thomas.Engstroem@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Lønborg, MD PhD DMSci
Phone
+45 3545 8176
Email
jacob.thomsen.loenborg01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrøm, MD PhD DMSci
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacob Lønborg, MD PhD DMSci
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis Joshi, Md, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center, Rigshospitalet
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrom, MD PhD DSci
Phone
+4535458444
Email
thomas.engstroem@rh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Jacob Lønborg
Phone
+4535458176
Email
jacob.thomsen.loenborg01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Thomas Engstrom, MD PhD DSci
First Name & Middle Initial & Last Name & Degree
Jacob T Lønborg, MD PhD DMSci
First Name & Middle Initial & Last Name & Degree
Francis Joshi, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Intravascular Ultrasound Guided PCI in STEMI

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