The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions (FORECAST)

This study is currently recruiting participants.
Verified August 2012 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Ciro Indolfi, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01671631
First received: August 20, 2012
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.

Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.


Condition Intervention
Functional Evaluation of Non Culprit Lesions in ACS Patients
Other: Measurement of intracoronary pressure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University Magna Graecia:

Groups/Cohorts Assigned Interventions
Acute Coronary Syndrome
Patients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions.
Other: Measurement of intracoronary pressure

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Acute Coronary Syndrome and multivessel coronary artery disease.

Criteria

Inclusion Criteria:

  • age 40 to 80 years
  • recent Acute Coronary Syndrome
  • indication for coronary angiography
  • presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR):

Exclusion Criteria:

  • Haemodynamically significant valvular disease
  • controindication for Adenosin administration
  • previous CABG on the index vessel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671631

Contacts
Contact: Ciro Indolfi, Prof +3909613647067 clinicaltrials-cardioumg@email.it

Locations
Italy
Cardiologia Interventistica UMG Recruiting
Catanzaro, Calabria, Italy, 88100
Contact: Ciro Indolfi, Prof.    +3909613647067    clinicaltrials-cardioumg@email.it   
Principal Investigator: Ciro Indolfi, MD         
Sponsors and Collaborators
University Magna Graecia
  More Information

Additional Information:
No publications provided

Responsible Party: Ciro Indolfi, Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01671631     History of Changes
Other Study ID Numbers: FORECAST
Study First Received: August 20, 2012
Last Updated: August 22, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014