NCT05940285

Brief Summary

Dynamic 99mTc-Tetrofosmin CZT-SPECT myocardial perfusion imaging (MPI) is an advanced functional imaging technique giving important myocardial flow quantification added data in comparison with conventional MPI, especially in coronary multi vessel disease. A large-scale validation of diagnostic performances of myocardial flow reserve (MFR) estimated with Dynamic 99mTc-Tetrofosmin CZT-SPECT MPI would allow a non-invasive approach instead of invasive intra-coronary fractional flow reserve (FFR) measurement. The aim of this prospective study is to assess diagnostic performances of MFR calculated with dynamic 99mTc-Tetrofosmin CZT-SPECT MPI in comparison with invasive intra-coronary FFR measurement in patients with significant residual coronary arteries stenosis after acute coronary syndrome .

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress75%
Oct 2023Apr 2027

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

July 3, 2023

Last Update Submit

April 7, 2026

Conditions

Myocardial Infarction

Keywords

Dynamic 99mTc-Tetrofosmin CZT-SPECTMyocardial perfusion imagingfractional flow reserveacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR

    To determine MFR diagnostic performances in comparison with FFR

    within one month after ST-elevation myocardial infarction

Secondary Outcomes (4)

  • best MFR cut-off value

    within one month after ST-elevation myocardial infarction

  • MFR value correlated with IMR

    within one month after ST-elevation myocardial infarction

  • Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI

    within one month after ST-elevation myocardial infarction

  • Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value

    within one month after ST-elevation myocardial infarction

Study Arms (1)

Single arm study

EXPERIMENTAL

Patients included in the study will undergo subsequently at 1-month after acute coronary syndrome Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment

Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT

Interventions

Dynamic 99mTc-Tetrofosmin CZT-SPECTDIAGNOSTIC_TEST

Patients included in the study will undergo subsequently at 1-month after acute coronary syndrome Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment

Single arm study

Eligibility Criteria

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

You may qualify if:

  • Adult patient.
  • Multi vessel coronary arteries disease (at least one non-culprit coronary stenosis \>= 50%) diagnosis during
  • primary percutaneous coronary intervention \< 12h after ST-elevation myocardial infarction opercutaneous revascularisation of the culprit lesion within 24 to 48 hours of an acute non-ST-segment elevation coronary syndrome.
  • Written consent.
  • Social security affiliation

You may not qualify if:

  • Non adult patient.
  • Adult patient under tutelage.
  • Reproductive age women.
  • Medical history of myocardial infarction or coronary artery bypass surgery.
  • Cardiogenic shock.
  • Cardiomyopathy.
  • Regadenoson/adenosine/FFR contraindication.
  • mTc-Tetrofosmin hypersensibility.
  • Small non-culprit coronary arteries.
  • Participation to another interventional study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Myocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

October 20, 2023

Primary Completion

May 20, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

FR(1)