Functional Assessment of Myocardial Ischemia by Intracoronary Electrocardiogram

NCT03985241 | Completed DMC

• 1 other identifier: 2016-00726
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Stable Angina; Coronary Artery Stenosis; Ischemia

Keywords

Intracoronary Electrocardiogram; Fractional Flow Reserve; Collateral Flow Index; Dobutamine

Outcome Measures

Primary Outcomes (1)

• Intracoronary Electrocardiogram ST-Segment Shift

  Change in intracoronary ST-segment shift from baseline to hyperemia, measured at the J-Point in mV

  Measured at maximal heart frequency (=~6min after begin dobutamine)

Secondary Outcomes (4)

• Percent Diameter Stenosis

  During diagnostic angiography at the beginning of the coronary angiography

• Fractional Flow Reserve

  Measured at maximal heart frequency (=~6min after begin dobutamine)

• Instantaneous wave-free ratio

  Measured at baseline before inotropic stress

• Area at Risk

  Measured after the coronary angiography, expected to be on average after 3 days

Study Arms (1)

Functional Assessment of Myocardial Ischemia by icECG

EXPERIMENTAL

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

Interventions

Functional Assessment of Myocardial Ischemia by icECG DIAGNOSTIC_TEST

Functional Assessment of Myocardial Ischemia by icECG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Inselspital, Bern

Bern, Switzerland

Location

Related Links

• Friedman et al. Circulation 1986 - Value of the intracoronary electrocardiogram to monitor myocardial ischemia during percutaneous transluminal coronary angioplasty.
• de Marchi et al. JACC 2012 - Determinants of prognostically relevant intracoronary electrocardiogram ST-segment shift during coronary balloon occlusion.

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Coronary Stenosis; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Christian Seiler, MD, Prof

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 13, 2019
• Study Start: December 3, 2016
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

CH (1)