NCT07646977

Brief Summary

The aim of this study is to evaluate the effects of coronary thrombus modification on preventing the microvascular damage associated with primary percutaneous coronary intervention (PCI), and to limit the associated myocardial damage assessed by myocardial salvage index after 3 months. Furthermore, the project will evaluate coronary microvascular damage assessed invasively using both continuous and bolus thermodilution before and after stent implantation. In addition, the project will evaluate the diagnostic ability and associations of pre-stenting invasive physiological measurement to cardiac magnetic resonance imaging measurements.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
92mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jan 2034

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2034

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

June 8, 2026

Last Update Submit

June 12, 2026

Conditions

ST Elevation Myocardial InfarctionCoronary Microvascular DysfunctionPercutaneous Coronary Intervention

Keywords

Microvascular damageContinuous thermodilutionBolus thermodilutionMyocardial damageCardiac MRI

Outcome Measures

Primary Outcomes (1)

  • Myocardial salvage index

    Calculated as the ratio of undamaged myocardium at 3 months to the area-at-risk ((Area-at-risk - final infarct size)/Area-at-risk)

    3 months

Secondary Outcomes (16)

  • CMR metrics of myocardial damage

    within 7 days and after 3 months

  • Left ventricular volumes by CMR

    within 7 days after index procedure and after 3 months

  • LVEF measured by CMR

    within 7 days of index procedure and after 3 months

  • MVO measured by CMR

    within 7 days and after 3 months

  • IMH measured by CMR

    within 7 days and after 3 months

  • +11 more secondary outcomes

Study Arms (2)

Coronary thrombus modification

EXPERIMENTAL
Procedure: Coronary thrombus modification

Standard stent implantation

ACTIVE COMPARATOR
Procedure: Standard stent implantation

Interventions

Coronary thrombus modificationPROCEDURE

Inflation of a short balloon not larger than the vessel size for 30 seconds following deflation for 30 seconds repeated a total of 4 times. Thereafter, patients will undergo standard stent implantation as per operator decision.

Coronary thrombus modification
Standard stent implantationPROCEDURE

Predilation before stent implantation will follow normal clinical guidelines, and to the discretion of the operator. patients will undergo standard stent implantation as per operator decision.

Standard stent implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ST-elevation at the J-junction in a minimum of two contiguous ECG leads with a minimum of ≥ 0.1 mV in all leads, except for V2 and V3 (which required ≥ 0.2 for men ≥ 40 years old, ≥ 0.25 in men \< 40 years old, or ≥ 0.15 mV for all women) or new left bundle branch
  • Admission to hospital within 12 hours of symptom debut
  • Angiographic signs of a culprit lesion planned to be treated with primary percutaneous coronary intervention

You may not qualify if:

  • Age \< 18 years or inability to provide informed consent
  • Life expectancy of \< 12 months
  • Hemodynamically instability
  • Pregnancy or breastfeeding
  • Known asthma or severe chronic obstructive pulmonary disease
  • Expected inability to perform physiological measurements (due to severely tortuous arteries, ostial disease or very distal disease),
  • CMR contraindications (estimated glomerular filtration rate \< 30 mL/min, magnetic or mechanically activated implants, or any prior metal implants, severe claustrophobia)
  • Expected to or unavoidable to use thrombectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Analysis of CMR data will be performed blided to group assignment and invasive measurement results
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clincial trial with 1:1 randomization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

January 1, 2034

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

IPD used in the results publication

Access Criteria
Upon reasonable request

Locations

DK(1)