Use of Atropine in Tredmill Stress Testing

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mohamed Jabaren, HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT00623207

First received: February 14, 2008

Last updated: July 24, 2015

Last verified: July 2015

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 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

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

Further study details as provided by Mohamed Jabaren, 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 ]


Enrollment:	103
Study Start Date:	December 2007
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (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 (Adult, Senior)
Sexes 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

Locations


Israel
Heart Institute, Ha'Emek Medical Center
Afula, Israel, 18100

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information


Responsible Party:	Mohamed Jabaren, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00623207 History of Changes
Other Study ID Numbers:	07-0139 EMC
Study First Received:	February 14, 2008
Last Updated:	July 24, 2015

Keywords provided by Mohamed Jabaren, HaEmek Medical Center, Israel:


Chest Pain Low work Capacity Rate Incompetence

Additional relevant MeSH terms:


Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Atropine Adjuvants, Anesthesia Anti-Arrhythmia Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017

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