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NCT00623207 Clinical Trial

Use of Atropine in Tredmill Stress Testing

Chest Pain Clinical Trial

Official title:
Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00623207
Other study ID # 07-0139 EMC
Secondary ID
Status Completed
Phase Phase 3
First received February 14, 2008
Last updated July 24, 2015
Start date December 2007
Est. completion date October 2009

Study information
Verified date July 2015
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Atropine
I.V Atropine 0.5mg up to 2 mg

Locations
Country Name City State
Israel Heart Institute, Ha'Emek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 yaer Yes
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