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Functional Assessment of Myocardial Ischemia by Intracoronary Electrocardiogram (FFRicECG)

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ClinicalTrials.gov Identifier: NCT03985241
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

In patients with chronic stable coronary artery disease (CAD), percutaneous coronary intervention (PCI) targets hemodynamically significant coronary lesions, i.e., those thought to cause inducible ischemia. The hemodynamic severity of a coronary stenosis increases with its tightness and with the myocardial mass of viable myocardium downstream of the stenosis.

Compared to the traditional anatomic angiographic approach, assessment of functional relevance by fractional flow reserve (FFR) during coronary angiography has been suggested to improve patient outcomes. Fractional flow reserve (FFR) is based on determination of the coronary perfusion pressure downstream of a stenosis during pharmacologic hyperemia. However, FFR relies on oversimplified physiologic concepts, which limits its usefulness in defining a true ischemic threshold. Furthermore, visual angiographic assessment continues to dominate the treatment decisions for intermediate coronary lesions.

Conversely, the intracoronary ECG (icECG) provides an inexpensive, sensitive and direct measure of myocardial ischemia. The icECG is easily acquired by attaching a reusable alligator clamp to a conventional angioplasty guidewire (at one tenth the price of a pressure sensor guidewire). The coronary guide wire positioned downstream of a coronary stenosis then acts as the exploring electrode. During pharmacologic stress, the icECG can provide direct evidence for regional myocardial ischemia to define the ischemic threshold in different types of coronary artery disease.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Stable Angina Coronary Artery Stenosis Ischemia Diagnostic Test: Functional Assessment of Myocardial Ischemia by icECG Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Assessment of Myocardial Ischemia by Intracoronary Electrocardiogram
Actual Study Start Date : December 3, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional Assessment of Myocardial Ischemia by icECG
Evaluation of ST-Shifts in the icECG acquired downstream of a coronary lesion during pharmacologic inotropic stress using dobutamine (40mcg/kg/min).
Diagnostic Test: Functional Assessment of Myocardial Ischemia by icECG



Primary Outcome Measures :
  1. Intracoronary Electrocardiogram ST-Segment Shift [ Time Frame: Measured at maximal heart frequency (=~6min after begin dobutamine) ]
    Change in intracoronary ST-segment shift from baseline to hyperemia, measured at the J-Point in mV


Secondary Outcome Measures :
  1. Percent Diameter Stenosis [ Time Frame: During diagnostic angiography at the beginning of the coronary angiography ]
    Assessment of percent diameter Stenosis using quantitative coronary angiography; comparison with icECG

  2. Fractional Flow Reserve [ Time Frame: Measured at maximal heart frequency (=~6min after begin dobutamine) ]
    FFR during steady-state hyperemia; comparison with icECG

  3. Instantaneous wave-free ratio [ Time Frame: Measured at baseline before inotropic stress ]
    iFR at baseline; comparison with icECG

  4. Area at Risk [ Time Frame: Measured after the coronary angiography, expected to be on average after 3 days ]
    Myocardial area at risk in percent using the Approach-Score and relation to intracoronary ECG ST-Segment shift



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Referred for elective coronary angiography
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Acute coronary syndrome
  • Severe aortic stenosis
  • Acute congestive heart failure NYHA III-IV
  • Prior myocardial infarction in the vascular territory undergoing pressure measurements
  • Presence of left bundle branch block, non-sinus rhythm or paced rhythm in resting ECG
  • Coronary anatomy unsuitable for coronary pressure measurements
  • Severe pulmonary, renal or hepatic disease
  • Contraindication to inotropic stress
  • Women of childbearing age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985241


Contacts
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Contact: Christian Seiler, MD, Prof +41 31 632 3693 christian.seiler@insel.ch
Contact: Marius R Bigler, MD +41 31 632 80 30 mariusreto.bigler@insel.ch

Locations
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Switzerland
University Hospital Inselspital, Bern Recruiting
Bern, Switzerland
Contact: Christian Seiler, Prof    +41 31 632 3693    christian.seiler@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Christian Seiler, MD, Prof Inselspital, Bern University Hospital

Additional Information:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03985241     History of Changes
Other Study ID Numbers: 2016-00726
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
Intracoronary Electrocardiogram
Fractional Flow Reserve
Collateral Flow Index
Dobutamine

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Coronary Stenosis
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents