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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

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

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

NCT ID

NCT04775914

First Posted

February 17, 2021

Last Updated

January 18, 2023

Sponsor

Thomas Engstrom

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

Studies a U.S. FDA-regulated Device Product

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

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

Thomas.Engstroem@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Jacob Lønborg, MD PhD DMSci

Phone

+45 3545 8176

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

thomas.engstroem@rh.regionh.dk

First Name & Middle Initial & Last Name & Degree

Jacob Lønborg

Phone

+4535458176

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

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Intravascular Ultrasound Guided PCI in STEMI

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