NCT02358148

Brief Summary

This prospective observational study will evaluate and compare the sensitivity and specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during coronary angiography in the cardiac catheterization suite. In addition, we plan to determine if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from two or all three scores yields a new tool that exceeds the predictive performance of all three current models for determining the absence or presence of OCAD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

February 3, 2015

Last Update Submit

July 18, 2016

Conditions

Chest PainAcute Coronary SyndromeAnginaMyocardial Infarction

Keywords

Acute Coronary SyndromeChest PainACSRisk Stratification ScoreHEART ScoreModified TIMICoronary Artery DiseaseRisk FactorsMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Angiographic Findings of Cardiac Catheterization

    Interventional Cardiologist's Diagnosis resulting from coronary angiography during Cardiac Catheterization - will determine which one of the following SECONDARY OUTCOME categories the patient is placed in:

    30 days from enrollment

Secondary Outcomes (5)

  • No CAD noted - no coronary interventions indicated

    30 days from study enrollment

  • Mild-moderate CAD noted - no coronary artery interventions are indicated

    30 days from study enrollment

  • Obstructive CAD present, no myocardial injury, immediate intervention is indicated

    30 days from study enrollment

  • Obstructive CAD present with myocardial infarction/ injury

    30 days from study enrollment

  • No Obstructive CAD present but myocardial damage is evident

    30 days from study enrollment

Study Arms (2)

STEMI / NSTEMI

All patients (100%) admitted to the participating hospitals during the study period with the diagnosis of Acute ST Segment Myocardial Infarction (STEMI) or Non-ST Segment Myocardial Infarction (NSTEMI) will be selected for inclusion in the study. In order to assure rapid door-to-reperfusion times, Study Investigators will obtain consent and interview these patients AFTER cardiac catheterization and intervention. A minimum number of 25 STEMI and 25 NSTEMI patients will be enrolled in the study.

Elective / Non-emergent Cardiac Cath

This group will include both admitted and outpatients, with possible diagnoses of Unstable Angina (UA), Low Risk Chest Pain (LRCP), and those having cardiac catheterization for any other reason (eg: elective, medical clearance for surgery, failed stress test, etc.). To maintain integrity of the study, these patients will be randomly selected, with written consent obtained, prior to cardiac catheterization.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients selected in this study will be patients who are having URGENT (Group 1) or NON-URGENT (Group 2) cardiac catheterization performed: Group 1: All (100%) of STEMI / Non-STEMI patients presenting for cardiac catheterization during the study period, with a minumum number of 25 STEMI and 25 NSTEMI patients to be included. Group 2: Non-urgent cardiac catheterization patients will be randomly selected, with consents obtained, PRIOR TO elective cardiac catheterization.

You may qualify if:

  • Any patient presenting to the Cardiac Catheterization Lab during the study period.

You may not qualify if:

  • Patients who refuse / wish to not be included in the study,
  • Patients with Wolff-Parkinson-White syndrome with visible Delta waves on the ECG.
  • Patients with Renal Failure and abnormally elevated Creatinine \>2.0
  • Patients with Potassium values \>6.0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bayfront Health Dade City

Dade City, Florida, 33525, United States

Location

Bayfront Health St Petersburg

St. Petersburg, Florida, 33701, United States

Location

Related Publications (2)

  • Macdonald SP, Nagree Y, Fatovich DM, Brown SG. Modified TIMI risk score cannot be used to identify low-risk chest pain in the emergency department: a multicentre validation study. Emerg Med J. 2014 Apr;31(4):281-5. doi: 10.1136/emermed-2012-201323. Epub 2013 Apr 10.

    PMID: 23576231RESULT

  • Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.

    PMID: 23465250RESULT

Related Links

MeSH Terms

Conditions

Chest PainAcute Coronary SyndromeAngina PectorisMyocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Wayne W Ruppert, CVT, CCCC

    Bayfront Health Dade City

    PRINCIPAL INVESTIGATOR

  • Ravi Korabathina, MD, FSCAI

    Bayfront Health St Petersburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac Data Specialist and Cardiovascular Clinical Coordinator

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

US(2)