Use of Atropine in Tredmill Stress Testing
This study has been completed.
Sponsor:
HaEmek Medical Center, Israel
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
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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:
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 ]
| 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) |
| 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
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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
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 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by 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 September 30, 2016