Acute CholecystitisNCT01706068
Transient ECG Changes in Patients With Acute Biliary Disease
An observational study of Acute Cholecystitis and Biliary Colic, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Cholecystitis, Biliary Colic, Acute Cholangitis
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ECG changes
Who may be able to join
- Patients from age 18 and up to 75years old.
- Causes of admission to the ED are acute cholecystitis, biliary colic, acute cholangitis
- The patient is willing to participate in the study and is able to sign an informed consent form.
Who cannot join
- Elective hospitalization with known and not acute condition.
- Inability to give inform consent .
- Sepsis as complication of illness.
- Chronic ECG changes known by medical history.
- Knowing history of IHD.
- Previous cardiac catheterization with documented stenosis of at least 1 major coronary artery equal or more 50%.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv Medical Center
Safed, 13100
Inna Rozenfeld, MD, 972508434217, innacardros@yahoo.com
Inna Rozenfeld, MD
About this study
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.
Read more
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.
- Conditions
- Acute Cholecystitis, Biliary Colic, Acute Cholangitis
- Keywords
- acute ECG changes, acute illness of gallbladder, acute illness of biliary tract
- Medical subject headings
- Cholecystitis, Acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Inna Rozenfeld , MD, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706068
- Sponsor's protocol ID
- ECGCTIL
- Status last verified
- Oct 2012
- First submitted
- 10 Oct 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient ECG Changes in Patients With Acute Biliary Disease
- ClinicalTrials.gov ID
- NCT01706068
- Acronym / sponsor ID
- ECGCTIL
- Conditions
- Acute Cholecystitis, Biliary Colic, Acute Cholangitis
- Keywords
- acute ECG changes, acute illness of gallbladder, acute illness of biliary tract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ECG changes
Key inclusion criteria (3 listed)
- Patients from age 18 and up to 75years old.
- Causes of admission to the ED are acute cholecystitis, biliary colic, acute cholangitis
- The patient is willing to participate in the study and is able to sign an informed consent form.
Key exclusion criteria (6 listed)
- Elective hospitalization with known and not acute condition.
- Inability to give inform consent .
- Sepsis as complication of illness.
- Chronic ECG changes known by medical history.
- Knowing history of IHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Related trials for Acute Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis and Biliary Colic, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.