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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00192790
Other study ID # ZSA1871CTIL
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated April 10, 2007
Start date January 2004
Est. completion date March 2005

Study information

Verified date April 2007
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

To explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.


Description:

Objective: Silent myocardial infarction (MI) is an event of severe myocardial ischemia without pain experience. The lack of pain alarm leads to increased morbidity and mortality, because the patients do not sick timely medical treatment. This study aims to explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.

Methods: Level of chest pain intensity was assessed by visual analogue scale (VAS), range from 0 (no pain) to 100 (maximal pain). Heat pain threshold, magnitude estimation of supra-threshold painful stimuli at 47ºC as well as pain catastrophizing scores were assessed in 90 acute MI patients (mean age 66±12.1, range 33-79) with chest pain (n=65) and without pain symptoms(n=25). All stimuli were performed by Thermal Sensory Analysis (TSA) and applied to the right forearm.

Results: The demographic variables, history of ischemic heart, risk factors for coronary artery disease, ST-T segment changes on ECG and troponin levels were similar in both groups. Greater intensity of chest pain VAS scores was inversely correlated with lower pain threshold (r= -0.417, p<0.001), and directly associated with higher pain scores in response to the heat pain (r=0.354, p=0.002). Patients with painful MI demonstrated lower pain threshold (41.9±3.6 vs. 44.9±3.8, p=0.001), higher VAS scores in response to the supra-threshold painful stimuli (50.2 ±21.8 vs. 27.0±25.2, p=0.002), and higher catastrophizing level (10.6±12.0 vs. 5.4±8.8, p=0.032). Chest pain complaint was not related to ST-T changes as well as concomitant diseases.

Conclusions: This study suggests that reduced systemic pain perception as well as cognitive personality variables play an important role in the etiology of Silent MI.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:All patients with painless or painful myocardial infarction -

Exclusion Criteria:Patients who can't give informed concent or couldn't cooperate

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Locations

Country Name City State
Israel RAMBAM Health Care Campus, Internal Medicine "B" & Cardiology Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

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