Transient ECG Changes in Patients With Acute Biliary Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Inna Rozenfeld , MD, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01706068
First received: October 10, 2012
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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.


Condition
Acute Cholecystitis
Biliary Colic
Acute Cholangitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Transient ECG Changes in Patients With Acute Biliary Disease

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ECG changes

Criteria

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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706068

Locations
Israel
Ziv Medical Center Not yet recruiting
Zefat, Israel, 13100
Contact: Inna Rozenfeld, MD    972508434217    innacardros@yahoo.com   
Principal Investigator: Inna Rozenfeld, MD         
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Inna Rozenfeld , MD, Principal Investigator, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01706068     History of Changes
Other Study ID Numbers: ECGCTIL
Study First Received: October 10, 2012
Last Updated: October 12, 2012
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Ziv Hospital:
acute ECG changes
acute illness of gallbladder
acute illness of biliary tract

Additional relevant MeSH terms:
Cholangitis
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Cholecystitis, Acute
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014