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Angina PectorisiFR SwedeheartNCT02166736

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

A study testing iFR and FFR in people with Angina Pectoris and Acute Myocardial Infarction, run by Uppsala University at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Angina Pectoris, Acute Myocardial Infarction
What is being tested?
iFR and FFR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,037 participants
Where
14 sitesin 3 countries
Study dates
May 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with suspected stable angina pectoris or unstable angina pectoris/non-ST-segment elevation myocardial infarction (NSTEMI) who are scheduled to undergo coronary angiography, and who has an indication for physiology guided assessment of coronary lesions (usually 30-80% stenosis grade). In patients with suspected stable angina pectoris, any lesion may be assessed. In patients with unstable angina pectoris/NSTEMI, only the non-culprit lesion may be assessed.

Who cannot join

  • Inability to provide informed consent
  • Age below 18 years
  • Previous randomization in the iFR-SWEDEHEART trial
  • Known terminal disease with a life expectancy of less than one year.
  • In patients with multi-vessel disease and other indication than stable angina pectoris, difficulty in assessing which the culprit lesion is.
  • Patient with unstable hemodynamics (Killip class III-IV)
Show all 9Show fewer
  • Inability to tolerate Adenosine
  • Previous Coronary artery bypass graft (CABG) with patent grafts to the interrogated vessel.
  • Heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire is expected.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Sweden12 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Halmstad sjukhus

    Halmstad

  • Helsingborg County Hospital

    Helsingborg

  • Kalmar County Hospital

    Kalmar

  • Karlstad County Hospital

    Karlstad

  • Linköping University Hospital

    Linköping

  • Skane University Hospital

    Lund

  • Örebro University Hospital

    Örebro

  • S:t Göran County Hospital

    Stockholm

  • Sundsvall County Hospital

    Sundsvall

  • Uppsala University Hospital

    Uppsala

  • Västerås County Hospital

    Västerås

Other trials in Sweden

Denmark1 site

  • Skejby University Hospital

    Aarhus

Other trials in Denmark

Iceland1 site

  • Reykjavik University Hospital

    Reykjavik

Other trials in Iceland

About this study

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

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.

Read more

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.

Being tested
iFR, FFR
Keywords
Instantaneous wave Free Ratio, Fractional Flow Reserve
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iFRDevice

    Treatment guided by Instantaneous wave-free ratio (iFR®)

  • FFRDevice

    Intervention guided by Fractional Flow Reserve

Study groups in NCT02166736
Study groupRoleWhat they receive
Instantaneous wave-free ratio (iFR)ExperimentalNot described
Receives: Device: iFR
Fractional Flow Reserve (FFR)Active comparatorNot described
Receives: Device: FFR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization

    Measured: 12 months

Secondary outcomes (8)

  1. All cause death

    Measured: 1-5 years

  2. Non-fatal MI

    Measured: 1-5 years

  3. Unplanned revascularization

    Measured: 1-5 years

  4. Target lesion revascularization

    Measured: 1-5 years

  5. Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

    Measured: 1-5 years

  6. Change in physician´s treatment strategy depending on iFR/FFR information

    Before randomization, the operators will have to record their angiographic assessment of the coronary lesions and the theoretical treatment strategy based on the angiographic information alone. After randomization and functional assessment of lesion severity, the operators will record how iFR/FFR changed the treatment strategy.

    Measured: Day 1

  7. Assessment of patient discomfort during the procedure (none/mild/moderate/severe

    Measured: Day 1

  8. Procedural time

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionOct 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,037 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166736
Sponsor's protocol ID
U-2013-044
Acronym
iFR Swedeheart
Status last verified
Jan 2017
First submitted
7 May 2014
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Eftekhari A, Holck EN, Westra J, Olsen NT, Bruun NH, Jensen LO, Engstrom T, Christiansen EH. Instantaneous wave free ratio vs. fractional flow reserve and 5-year mortality: iFR SWEDEHEART and DEFINE FLAIR. Eur Heart J. 2023 Nov 1;44(41):4376-4384. doi: 10.1093/eurheartj/ehad582.

    PubMed 37634144

  • Berntorp K, Rylance R, Yndigegn T, Koul S, Frobert O, Christiansen EH, Erlinge D, Gotberg M. Clinical Outcome of Revascularization Deferral With Instantaneous Wave-Free Ratio and Fractional Flow Reserve: A 5-Year Follow-Up Substudy From the iFR-SWEDEHEART Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e028423. doi: 10.1161/JAHA.122.028423. Epub 2023 Feb 3.

    PubMed 36734349

  • Gotberg M, Berntorp K, Rylance R, Christiansen EH, Yndigegn T, Gudmundsdottir IJ, Koul S, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Venetsanos D, James SK, Karegren A, Carlsson J, Jensen J, Karlsson AC, Erlinge D, Frobert O. 5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve. J Am Coll Cardiol. 2022 Mar 15;79(10):965-974. doi: 10.1016/j.jacc.2021.12.030.

    PubMed 35272801

  • Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.

    PubMed 28317438

  • Gotberg M, Christiansen EH, Gudmundsdottir I, Sandhall L, Omerovic E, James SK, Erlinge D, Frobert O. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2015 Nov;170(5):945-50. doi: 10.1016/j.ahj.2015.07.031. Epub 2015 Aug 15.

    PubMed 26542503

Questions about this trial

What is this clinical trial studying?

A study testing iFR and FFR in people with Angina Pectoris and Acute Myocardial Infarction, run by Uppsala University at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Sweden, Denmark, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166736, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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