Prediction Value of Ecg on Coronary Slow-flow

Completed

• Conditions: Coronary Slow Flow
• Interventions: Procedure: angiography

• Registration Number: NCT02650557
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.

Detailed Description

Coronary slow flow (CSF) phenomenon, which is characterized by delayed coronary opacification in the absence of obstructive epicardial coronary artery disease, is a relatively common finding in patients undergoing routine coronary angiography and is often associated with chest pain. In some patients with CSF, blood flow may be heterogeneously distributed in the three coronary arteries, suggesting the heterogeneously distributed microvascular dysfunction in the myocardium. However, the vessel heterogeneity of Thrombolysis in Myocardial Infarction (TIMI) frame count (TFC) has not been fully elucidated.

P-wave dispersion (PWD) is defined as the difference between the longest and the shortest P-wave duration recorded from multiple different surface electrocardiogram (ECG) leads, and it has been reported to be associated with inhomogeneous and discontinuous propagation of sinus impulses5, which are well known electrophysiologic characteristics of the atrium prone to fibrillation. Although it is plausible to hypothesize that PWD might be associated with the heterogeneously distributed microvascular dysfunction, and previous studies have demonstrated the abnormal PWD in patients with CSF, the correlation between TFC heterogeneity and PWD has never been evaluated.

In this study, the investigators aimed to investigate the vessel heterogeneity of TFC in the three coronary arteries, and its relation to PWD, in patients with CSF and otherwise normal coronary arteries.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Study First Submitted: 2016-01-03
• Study First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Study First Posted: 2016-01-08
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 998

Inclusion Criteria

• All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography

Exclusion Criteria

• Valvular or congenital heart disease
• Atrial fibrillation or other arrhythmia that would interfere with ECG analysis
• Left ventricular hypertrophy
• Myocardial or pericardial disease
• Chronic obstructive pulmonary disease, or electrolyte abnormalities.
• Subjects taking antiarrhythmic, antiischemic, β-blocker, or calcium-channel blocker medications were also excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CSF group	angiography	consecutive patients with angiographically documented CSF
control group	angiography	age- and gender-matched control subjects

Primary Outcome Measures

Name	Time	Method
Average thrombolysis in myocardial infarction (TIMI) frame count (TFC) in the three coronary arteries and its relation to P waves parameters on ECG in patients with CSF and otherwise normal coronary arteries	24-72 hours	The first frame was defined as the frame in which concentrated dye occupies the full width of the proximal coronary artery lumen, touching both borders of the lumen, and indicates forward motion down the artery. The final frame counted is that in which the contrast first reaches the distal predefined landmark branch without the necessity for full opacification. The difference between maximum and minimum P wave duration (Pmax and Pmin) was calculated from the 12-lead ECG and defined as PWD.

Secondary Outcome Measures

Name	Time	Method
maximum and minimum P wave duration (Pmax and Pmin) and major adverse cardiac events (MACE) in patients with CSF and otherwise normal coronary arteries	24 hours-30 days	The occurrence of major adverse cardiac events, defined as (1) death, (2) nonfatal myocardial infarction, or (3) target vessel revascularization. Myocardial infarction was diagnosed by a rise in the creatine kinase level to more than twice the upper normal limit with an increased creatine kinase-MB. Target lesion revascularization was defined as a repeat intervention (surgical or percutaneous) to treat a luminal stenosis within the stent or in the 5-mm distal or proximal segments adjacent to the stent. Target vessel revascularization was defined as a reintervention driven by any lesion located in the same epicardial vessel. Thrombotic stent occlusion was angiographically documented as a complete occlusion (TIMI flow 0 or 1) or a flow-limiting thrombus (TIMI flow 1 or 2) of a previously successfully treated artery.

Trial Locations

Locations (1)

Xiaodong Zhaung; 🇨🇳 Guangzhou, Guangdong, China