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Completed

NCT Number: NCT05421169

Diastolic Hyperemia-Free Ratio in Patients With CAD

The investigators aimed to identify the value of concordance between the diastolic hyperemia-free ratio (DFR) and fractional flow reserve (FFR) during pre-interventional and post-interventional period using a 0.014" COMET II Pressure Guidewire

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Key information

Conditions

Coronary Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

About this study

The physiologic assessment of coronary artery disease and ischemia-guided percutaneous coronary intervention (PCI) has become a standard practice for patients with coronary artery disease. Fractional flow reserve (FFR) represents hyperemic flow limitation caused by an epicardial coronary stenosis and its clinical usefulness has been proven by many clinical studies. However, the FFR is limited to clinical use despite the fact that it is recommended by the guideline due to the inconvenience of patients using medications used to induce maximum hyperemia, and the need for additional procedure time. Recently, a physiologic index which does not require hyperemia, instantaneous wave free ratio (iFR), was introduced and recent trials showed non-inferiority of iFR-guided strategy for 1-year clinical outcome, compared with FFR-guided strategy. Recently, not only iFR but also various intravascular pressure measurement techniques have been developed, one of which is diastolic hyperemia-free ratio (DFR). DFR uses the mean Pd/Pa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure. DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization in patients with NSTEMI. In the case of DFR, there is no issue in terms of safety because it is conducted in the same way as iFR, but there are not many studies on the validation between DFR and FFR. Therefore, the present study aimed to identify the quality of concordance between DFR and FFR, determine the features associated with discrepancies in DFR and FFR.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients, ≥ 19 years of age, who are diagnosed with stable angina pectoris including silent ischemic heart disease and 50~90% stenosis of the coronary artery.
  • Acute coronary syndrome patients with multivessel disease who have 50~90% stenosis of a non-culprit vessel on coronary angiography.

Exclusion criteria

  • Patients with acute coronary syndrome and single vessel disease.
  • Patients with hypersensitivity or contraindication to antiplatelet treatment.
  • Female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
  • Patients with a life expectancy shorter than 1 year.

Treatment and study plan

diastolic hyperemia-free ratio (DFR)

Diagnostic Test

diastolic hyperemia-free ratio uses the mean Pd/Pa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure

Primary outcomes

  1. Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80

    Time frame: through study completion, an average of 1 year

    Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions with a cut-off point to defer the treatment of FFR< = 0.80 (with intravenous sigmart) and DFR < = 0.89.

Secondary outcomes

  1. Comparison of the value between DFR <=0.89 and Pd/Pa <=0.92

    Time frame: through study completion, an average of 1 year

    Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions with a cut-off point to defer the treatment of and DFR < = 0.89 and Pd/Pa <=0.92.

    Pd/Pa (resting distal to aortic coronary pressure) was evaluated as the ratio of mean aortic pressure (Pa) to mean distal coronary arterial pressure (Pd), After getting the Pd/Pa value, investigators performed DFR computation considering average Pd/Pa during the period between Pa less than mean Pa ending at systole and calculated using auto-mated algorithms (Boston scientific) acting during a minimum of three beats.

  2. Comparison of post-interventional value between DFR >=0.89 and FFR >=0.80 when DFR/FFR-guided PCI is performed.

    Time frame: through study completion, an average of 1 year

    When the patients refered to PCI due to FFR <=0.80 or DFR <=0.89 for coronary stenotic lesion, investigators compared with post-interventional value between DFR and FFR after PCI.

  3. Comparison of the delta value (Δ post-interventional - pre-interventional value) between DFR and FFR.

    Time frame: through study completion, an average of 1 year

    When PCI will be conduced, the comparison of the delta value between pre and post value of DFR and FFR will be measured.

  4. Discordance factors between DFR >=0.89 and FFR >=0.80

    Time frame: through study completion, an average of 1 year

    After assessment of DFR and FFR, the investigators collected the date of mismatch between DFR >=0.89 and FFR >=0.80 and analyzed the discordance factors between DFR >=0.89 and FFR >=0.80

  5. Mortality within 30 days

    Time frame: through study completion, an average of 1 year

    umber of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock within 30 days

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Boston Scientific Corporation
  • Severance Hospital

Registry information

Official study title

Invasive funCtional assEssment Using Diastolic HypEremia-Free RATio in Patient With Coronary Artery Disease: a Prospective Observation Study (ICE-HEAT)

Acronym: ICE-HEAT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 16, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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