Intracoronary ECG ST-segment Shift Remission Time During Reactive Coronary Hyperemia

NCT05583786 | Unknown

• 1 other identifier: 2022-00522
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a new diagnostic approach based on intracoronary electrocardiogram (icECG) ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance.

Conditions

Chronic Coronary Syndrome

Keywords

Intracoronary electrocardiogram; icECG; Reactive-hyperemia; Balloon occlusion; Fractional flow ratio; FFR

Outcome Measures

Primary Outcomes (1)

• icECG ST-segment shift remission time (τ-icECG)

  The primary study objective is to test reactive hyperemia τ-icECG as obtained immediately after a 1-minute upstream coronary artery balloon occlusion as a new method to determine the hemodynamic significance of a coronary artery stenosis. As primary reference method, reactive hyperemia FFR (cut-off 0.80) is employed.

  once after a 1-minute coronary ballon occlusion

Secondary Outcomes (3)

• Quantitative percent diameter narrowing (secondary reference) (%S)

  once after a 1-minute coronary ballon occlusion

• Reactive hyperemia FFR (primary reference)

  once after a 1-minute coronary ballon occlusion

• Instantaneous wave-free ratio (iFR)

  once before a 1-minute coronary ballon occlusion

Interventions

Tracing intracoronary electrocardiogram DIAGNOSTIC_TEST

icECG ST-segment shift remission time (τ-icECG) tracing during reactive-hyperemia, obtained immediately after a 1-minute upstream coronary artery balloon occlusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic coronary syndrome electively referred to the investigators department for coronary angiography.

You may qualify if:

• Chronic coronary syndrome
• Chronic stable 1-3 vessel coronary artery disease
• Coronary stenotic lesion of any diameter narrowing
• Age \> 18 years
• Referred for elective coronary angiography to the investigators institution
• Written informed consent to participate in the study

You may not qualify if:

• Acute coronary syndrome
• Unstable cardiopulmonary condition
• Severe aortic valve stenosis
• Acute congestive heart failure NYHA (New York Heart Association) III-IV
• ECG bundle branch blocks, non-sinus rhythm or paced rhythm
• Coronary anatomy unsuitable for coronary measurements
• Severe pulmonary, renal or hepatic disease
• Women of childbearing age (≤50years and ≤12months after the last menstruation)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (11)

• Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, Widimsky P, McCullough PA, Hunt D, Braunwald E, Yusuf S. Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials. JAMA. 2005 Jun 15;293(23):2908-17. doi: 10.1001/jama.293.23.2908.

  PMID: 15956636 BACKGROUND

• Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.

  PMID: 23996286 BACKGROUND

• Stegehuis VE, Wijntjens GW, Piek JJ, van de Hoef TP. Fractional Flow Reserve or Coronary Flow Reserve for the Assessment of Myocardial Perfusion : Implications of FFR as an Imperfect Reference Standard for Myocardial Ischemia. Curr Cardiol Rep. 2018 Jul 26;20(9):77. doi: 10.1007/s11886-018-1017-4.

  PMID: 30046914 BACKGROUND

• Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.

  PMID: 8637515 BACKGROUND

• Piccolo R, Niglio T, Di Gioia G, D'Anna C, De Rosa R, Strisciuglio T, Trimarco B, Piscione F, Galasso G. Adenosine-induced torsade de pointes complicating a fractional flow reserve measurement in a right coronary artery intermediate stenosis. Cardiovasc Revasc Med. 2013 Mar-Apr;14(2):118-20. doi: 10.1016/j.carrev.2012.12.010. Epub 2013 Feb 19.

  PMID: 23433828 BACKGROUND

• Stoller M, Seiler C. Reactive myocardial hyperaemia for functional assessment of coronary stenosis severity. EuroIntervention. 2017 Jun 2;13(2):e201-e209. doi: 10.4244/EIJ-D-16-00579.

  PMID: 27993753 BACKGROUND

• Friedman PL, Shook TL, Kirshenbaum JM, Selwyn AP, Ganz P. Value of the intracoronary electrocardiogram to monitor myocardial ischemia during percutaneous transluminal coronary angioplasty. Circulation. 1986 Aug;74(2):330-9. doi: 10.1161/01.cir.74.2.330.

  PMID: 2942314 BACKGROUND

• Pande AK, Meier B, Urban P, Moles V, Dorsaz PA, Favre J. Intracoronary electrocardiogram during coronary angioplasty. Am Heart J. 1992 Aug;124(2):337-41. doi: 10.1016/0002-8703(92)90595-m.

  PMID: 1636577 BACKGROUND

• Hishikari K, Yonetsu T, Lee T, Koura K, Murai T, Iwai T, Takagi T, Isobe M, Iesaka Y, Kakuta T. Intracoronary electrocardiogram ST-segment elevation in patients with non-ST-segment elevation myocardial infarction and its association with culprit lesion location and myocardial injury. EuroIntervention. 2014 May;10(1):105-12. doi: 10.4244/EIJV10I1A17.

  PMID: 24048173 BACKGROUND

• Balian V, Galli M, Marcassa C, Cecchin G, Child M, Barlocco F, Petrucci E, Filippini G, Michi R, Onofri M. Intracoronary ST-segment shift soon after elective percutaneous coronary intervention accurately predicts periprocedural myocardial injury. Circulation. 2006 Oct 31;114(18):1948-54. doi: 10.1161/CIRCULATIONAHA.106.620476. Epub 2006 Oct 23.

  PMID: 17060382 BACKGROUND

• Bigler MR, Stoller M, Praz F, Siontis GCM, Grossenbacher R, Tschannen C, Seiler C. Functional assessment of myocardial ischaemia by intracoronary ECG. Open Heart. 2021 Jan;8(1):e001447. doi: 10.1136/openhrt-2020-001447.

  PMID: 33462106 BACKGROUND

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christian Seiler, Prof

  Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea K Kieninger-Gräfitsch, MD

CONTACT

+41 31 632 21 11; andrea.kieninger-graefitsch@insel.ch

Christian Seiler, Prof

CONTACT

+41 31 632 21 11; christian.seiler@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 18, 2022
• Study Start: June 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: May 31, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)