Transient ECG Changes in Patients With Acute Biliary Disease

Acute Cholecystitis Clinical Trial

Official title:

Transient ECG Changes in Patients With Acute Biliary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01706068
• Other study ID #: ECGCTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 10, 2012
• Last updated: October 12, 2012
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2012
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

Background:

The importance of ischemic ECG changes including St segment elevation, ST segment depression or T wave inversion that indicate myocardial ischemia are well established and require appropriate investigation and treatment.

However, there is an abundance of clinical situation, with apparently ischemic ECG change not indicate traditionally coronary artery related ischemia and therefore require prompt recognition and treatment of underlying condition, that may be serious and life-threatened. For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte abnormalities, intracranial hemorrhage and hypothermia.

Together with them, an ECG ST segment changes may appeared in abdominal serious illness such as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive and toxic for myocardium substances released, the cause of ST segment changes in cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma rennin activity resulted by distension of the gallbladder.

The certain proportion of the patients with ECG changes actually didn't have coronary artery disease(9,15) or other acute cardiac condition and therefore require treatment of the underlie illness only without spend the time for cardiac investigation or special treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or unnecessary cardiac catheterization.

In the medical literature the investigators found some case reports and works about the ECG changes in acute biliary disease in patient with knowing cardiac disease and without it, but actually incidence of ECG changes that suggest but not represent an acute coronary illness isn't knowing.

Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical and laboratory characteristics that helps to differentiate this patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients from age 18 and up to 75years old.

2. Causes of admission to the ED are acute cholecystitis, biliary colic, acute cholangitis

3. The patient is willing to participate in the study and is able to sign an informed consent form.

Exclusion Criteria:

1. Elective hospitalization with known and not acute condition.

2. Inability to give inform consent .

3. Sepsis as complication of illness.

4. Chronic ECG changes known by medical history.

5. Knowing history of IHD.

6. Previous cardiac catheterization with documented stenosis of at least 1 major coronary artery equal or more 50%.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Cholangitis
• Acute Cholecystitis
• Biliary Colic
• Cholangitis
• Cholecystitis
• Cholecystitis, Acute
• Gallbladder Diseases

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel,