Characterization of Ischemia Related Changes in Esophageal Electrocardiography

NCT01390155 | Completed

• 1 other identifier: 058/11
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal electrocardiography (eECG) has important advantages compared to standard ECG recordings. Coronary artery disease leading to myocardial ischemia is very common and has potentially severe consequences for patients. To date, the investigators don't know the influence of ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG induced by balloon occlusion of coronary arteries in patients undergoing coronary angiography.

Conditions

Coronary Artery Disease

Keywords

Electrocardiography; Coronary Artery Disease; Atrial Fibrillation; Heart Atria; Coronary Circulation; Ischemia

Outcome Measures

Primary Outcomes (1)

• ST-segment-elevation/depression in the ECG at J-point and 80ms later

  0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion

Secondary Outcomes (5)

• Increase/decrease of T-wave amplitude

  0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion

• Relative ST-segment-elevation/depression

  0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion

• Sensitivity and specificity of the esophageal electrocardiogram detecting ischemic conditions (using the intracoronary ecg as gold standard)

  at the end of occlusion, expected on average to be 60 seconds

• New U-wave

  during the whole occlusion time, expected on average to be 60 seconds

• beat-to-beat alternans of the ST-segment

  during the whole occlusion time, expected on average to be 60 seconds

Study Arms (4)

1

Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left anterior descending coronary artery.

Procedure: Measurement of coronary collateral flow index

2

Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left circumflex artery.

Procedure: Measurement of coronary collateral flow index

3

Patients undergoing temporary myocardial ischemia produced by a one-minute occlusion of the proximal right coronary artery.

Procedure: Measurement of coronary collateral flow index

4

Patients undergoing temporary myocardial ischemia produced by a one-minute occlusion of the target vessel.

Procedure: Measurement of coronary collateral flow index

Interventions

Measurement of coronary collateral flow index PROCEDURE

One-minute balloon occlusion of the proximal left anterior descending coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.

1

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 referred for elective coronary angiography due to suspected or known coronary artery disease.

You may qualify if:

• Patients referred for elective coronary angiography
• Age \>/= 18 years
• Written informed consent to participate to this study

You may not qualify if:

• Seve mitral- or aortic valve disease
• Acute coronary infarction
• Known bleeding diathesis
• Systolic blood pressure \>200mmHg
• History of operations of the esophagus
• Active disease of the upper respiratory and gastroesophageal tract
• Radiofrequency ablation of atrial fibrillation, less than six weeks ago
• Right and left bundle branch block
• Significant Q-waves in the surface leads as indicators for prior myocardial infarction
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Cardiology, Bern University Hospital

Bern, Canton of Bern, 3010 Bern, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Vogel, MD, MD-PhD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 8, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

CH (1)