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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University Magna Graecia.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 August 27, 2014