Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02869906
Other study ID # 1510/2016 CE Lazio 1
Secondary ID
Status Recruiting
Phase N/A
First received August 9, 2016
Last updated August 16, 2016
Start date September 2015
Est. completion date December 2016

Study information

Verified date August 2016
Source Azienda Ospedaliera San Camillo Forlanini
Contact Carmine Musto, PhD
Phone +393396361601
Email cmusto@hotmail.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

Functional assessment of non-culprit lesions during percutaneous coronary intervention (PCI) in patients with acute coronary syndrome could improve risk stratification and shorten the duration of hospital stay by decreasing the need for additional non-invasive stress testing to detect residual myocardial ischemia. The investigators aimed to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).


Description:

BACKGROUND: Approximately 30% of patients who present with ST elevation myocardial infarction have multivessel coronary artery disease on angiography. Whether percutaneous coronary intervention (PCI) should be limited to the culprit lesion only or applied to all angiographically critical non-culprit lesions is still debatable. The FAME 2 study has shown that Fractional Flow Reserve (FFR)-guided PCI, with adenosine infusion, reduces the MACE compared to medical therapy alone. In fact, according to the recent ESC clinical guidelines, FFR guided PCI is in class I, evidence level A. Previous studies, have confirmed that FFR values of non-culprit coronary lesions in STEMI patients provided similar values in the acute phase compared to the subacute phase, 5-7 days after primary PCI. Consequently, it is possible to assess angiographically borderline non-culprit lesions during the acute phase and hence risk stratify STEMI patients, thus reducing the duration of hospital stay by decreasing the need for additional non-invasive stress testing to detect residual myocardial ischemia. However, the assessment of angiographically borderline lesions using FFR has its own limitations related to the use of adenosine, which increases the risk of bradyarrhythmias and high degree atrioventricular block, especially in the acute phase. This would make functional assessment of the non-culprit lesions not always possible during the acute phase.

Recently, a new functional algorithm, called "instantaneous wave-free ratio" (iFR) has been introduced. Similar to FFR, it gives a functional assessment of coronary lesions by measuring the trans-stenotic gradient during ventricular diastole, where intramyocardial resistance is minimal and constant. This phase has been shown to be comparable to the maximum hyperemic state of FFR assessment.

The measurement of iFR during the acute phase of STEMI has not yet been evaluated.

AIM: The aim of this study is to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).

METHOD: Patients undergoing primary PCI for STEMI and presenting with multivessel coronary disease (at least one ≥ 50% diameter stenosis in a non-infarct-related coronary artery) were enrolled in a prospective observational registry. Coronary lesions were evaluated with both iFR and FFR immediately after primary PCI (acute phase) and 7 ± 3 days later (subacute phase).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing primary PCI for STEMI and presenting with multivessel coronary disease (at least one = 50% diameter stenosis in a non-infarct-related coronary artery) were enrolled.

Exclusion Criteria:

- severe left ventricular dysfunction (Ejection Fraction <30%).

- Heart Failure

- Previous STEMI

- Severe sinus bradycardia

- Past medical history of Asthma

- TIMI flow 1,2

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
FFR and iFR
The investigators aimed to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).

Locations

Country Name City State
Italy Ospedale San Camillo Rome

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera San Camillo Forlanini

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reproducibility of iFR and FFR values in the non culprit lesion during STEMI in the acute and subacute phase. Comparison of iFR and FFR values for evaluating the functional significance of non-culprit coronary lesions in patients with STEMI, both during primary PCI and during staged procedures, 5-7 days No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03895983 - ST Segment Resolution After Primary Percutaneous Coronary Intervention.
Not yet recruiting NCT03252665 - Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI Phase 4
Completed NCT02026219 - Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction Phase 4
Completed NCT03247738 - Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI Phase 4
Recruiting NCT05461781 - Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO N/A
Recruiting NCT03561389 - iFR-guided Revascularization in STEMI
Completed NCT01538303 - Microvascular Dysfunction in Acute Myocardial Infarction (AMI) and Its Relation to Outcome
Recruiting NCT02979236 - Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI N/A
Completed NCT05705089 - Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI Phase 3
Completed NCT01897350 - Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial N/A
Not yet recruiting NCT03753269 - Early Intracoronary Administration of Fasudil in the Primary PCI of ST-segment-Elevation Myocardial Infarction Phase 4
Completed NCT03234348 - MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction Phase 3
Recruiting NCT03406832 - Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI N/A
Recruiting NCT03406819 - Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI N/A
Recruiting NCT03508232 - Doxycycline to Protect Heart Muscle After Heart Attacks Phase 2
Recruiting NCT04220736 - Early Prediction of QFR in STEMI-Pharmaco-invasice
Completed NCT03780335 - Early Prediction of QFR in STEMI-I
Recruiting NCT03787745 - Ischemic Postconditioning in STEMI Patients Treated With Primary PCI N/A
Recruiting NCT03621111 - A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction N/A
Recruiting NCT03764241 - Treatment of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant Phase 3