Use of Atropine in Tredmill Stress Testing

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by HaEmek Medical Center, Israel.
Recruitment status was Recruiting

Sponsor:

Information provided by:

HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT00623207

First received: February 14, 2008

Last updated: February 22, 2008

Last verified: February 2008

History of Changes

Purpose

The aim of this study is to evaluate the Safety and feasibility of atropine added during treadmill stress testing in patients with chronotropic incompetence or poor exercise capacity.

Our hypothesis is that we can increase heart rate by using atropin in these patients, so we will achieve more conclusive results.

Condition	Intervention	Phase
Chest Pain	Drug: Atropine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain Exercise and Physical Fitness

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

1- To characterize patients who can't achieve target heart rate at treadmill exercise test.2- To evaluate atropine added during treadmill stress testing in order to increase heart rate and achieave conclusive test. [ Time Frame: 1 yaer ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Pateints who achieve target haert rate or conclusive test will not be given Atropine	Drug: Atropine I.V Atropine 0.5mg up to 2 mg
Active Comparator: 2 Patients who won't achieve tarhet heart rate or conclusive results will be given Atropine	Drug: Atropine I.V Atropine 0.5mg up to 2 mg

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with chest pain without evidence of ischemia eligible for exercise test.
Age> 18 years old

Exclusion Criteria:

Absolute:

Patients with LBBB
Unstable Angina
Recent Myocardial Infarction
Un controlled Arrythmia
Congestive heart faliure
Severe symptomatic valvular heart disease
Acute Pulmonary Embolism
Acute perimyocarditis
Acute aortic dissection

Relative:

Lt main stenosis
Severe hypertention (Systolic> 200 mmHg; Diastolic > 100 mmHg)
Cardiomyopathy
Obstructiove abnormalities
Psychiatric disorders
High degree AV Block

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: NCT00623207

Contacts


Contact: Mohamed Jabaren, MD	972-4-6495273	jabaren_mo@clalit.org.il
Contact: Yoav Turgeman, MD	972- 4- 6494144	yoav_t@clalit.org.il

Locations


Israel
Heart Institute, Ha'Emek Medical Center	Recruiting
Afula, Israel, 18100
Contact: Mohamed Jabaren, MD 972- 4- 6495273 jabaren_mo@clalit.org.il

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information

No publications provided


Responsible Party:	Dr. Mohamed Jabaren, Ha'Emeh Medical Center, Afula
ClinicalTrials.gov Identifier:	NCT00623207 History of Changes
Other Study ID Numbers:	07-0139 EMC
Study First Received:	February 14, 2008
Last Updated:	February 22, 2008
Health Authority:	Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:


Chest Pain Low work Capacity Rate Incompetence

Additional relevant MeSH terms:


Atropine Adjuvants, Anesthesia Anti-Arrhythmia Agents Anti-Asthmatic Agents Autonomic Agents Bronchodilator Agents Cardiovascular Agents Central Nervous System Agents Cholinergic Agents Cholinergic Antagonists	Molecular Mechanisms of Pharmacological Action Muscarinic Antagonists Mydriatics Neurotransmitter Agents Parasympatholytics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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