Clinical Trials Logo
  1. Home
  2. Acute Myocardial Infarction
  3. NCT02166736

Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome — iFR Swedeheart  

Acute Myocardial Infarction Clinical Trial

Official title:
Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome. A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the Swedish Angiography and Angioplasty Registry (SWEDEHEART) Platform

Clinical Trial Summary

Previous trials have demonstrated that the use of physiological assessment of stenosis severity using fractional flow reserve (FFR) is superior to angiographic assessment in percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost associated with Adenosine.

Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for functional significance. The main benefits of the method compared to FFR are that the measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does not experience any discomfort from the measurement and procedural time could be shortened compared to when using FFR. This could potentially increase the adoption rate of physiologic assessment of coronary lesions.

The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with patients assessed by FFR.

Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT) which is a novel strategy to conduct clinical trials. The randomization will occur online in the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02166736
Study type Interventional
Source Uppsala University
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date December 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04451967 - Acute Myocardial Infarction Study in Northeastern China
Completed NCT05974397 - Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
Not yet recruiting NCT04072081 - Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Completed NCT02669810 - EXCELLENT (EXpanded CELL ENdocardiac Transplantation) Phase 2
Not yet recruiting NCT04104048 - Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Active, not recruiting NCT02915107 - The SORT OUT IX STEMI OCT Trial N/A
Completed NCT02896543 - The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction N/A
Completed NCT02490969 - Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19 N/A
Completed NCT02531165 - Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention N/A
Withdrawn NCT01901471 - Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock Phase 2
Completed NCT02312336 - A Pilot Study of Transcoronary Myocardial Cooling N/A
Recruiting NCT02071342 - Study of ABSORB Stent in Acute Myocardial Infarction N/A
Terminated NCT01972126 - MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction N/A
Completed NCT02070913 - COOL-AMI EU Case Series Clinical Study
Completed NCT01216995 - Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI) Phase 2
Completed NCT01887080 - Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program N/A
Withdrawn NCT01678339 - Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients N/A
Completed NCT01627457 - Heart Cycle Prestudy N/A