Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02745821|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Coronary Artery Disease||Device: Pressure Wire Certus, St. Jude Medical, USA||Not Applicable|
There is currently no data on invasive measurement of FFR, CFR and IMR in patients with diabetes mellitus. Studies such as RIPCORD has shown that using coronary angiography alone to guide revascularization strategy may be flawed in a significant proportion of patients.
Patients with diabetes mellitus are more likely to have diffuse CAD and microvascular disease. Current recommendation of invasive physiological assessment to guide percutaneous coronary intervention (PCI) is limited to FFR alone. This can be misleading in diffuse coronary artery disease and microvascular disease as both conditions are associated with higher FFR. The proportion of vessels which show discordance between FFR and CFR consistent with diffuse CAD and/or microvascular disease in patients has been shown to be as high as 30% in a study not exclusive to diabetics.
This is a pilot study of 50 patients referred for PCI based on angiographic stenosis of ≥50%. Comprehensive physiological assessment will be undertaken in target and non-target vessels to determine the prevalence of discordant FFR and CFR consistent with diffuse CAD and/or microvascular dysfunction in diabetics.
- Patients will receive an information sheet after initial invitation to participate in the study.
- Written informed consent will be obtained.
- Patients will undergo invasive assessment of FFR, CFR and IMR in non-target vessels.
- An optical coherence tomography (OCT) study will be performed to correlate physiological parameters with intravascular imaging for diffuse atheromatous disease.
- Patients will then undergo OCT and invasive assessment of FFR, CFR and IMR in the target vessel pre and post PCI.
- Any change in FFR, CFR and IMR post PCI will be recorded.
- All physiological parameters will be measured using the pressure wire from St. Jude Medical, USA (currently, Certus). Results will be grouped according to 4 possible permutations of FFR and CFR.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Coronary physiology
Non-target and target vessels of patients with diabetes mellitus referred for PCI will be assessed for FFR, CFR and IMR. Intravenous adenosine at 140 micrograms/kg/min will be used to induce maximal hyperemia.
Device: Pressure Wire Certus, St. Jude Medical, USA
FFR. CFR and IMR will be measured using the Pressure Wire Certus, St. Jude Medical, USA in target and non-target vessels. Changes in FFR, CFR and IMR post PCI of target vessels will also be recorded.
- Prevalence of number of vessels fulfilling each of 4 permutations of fractional flow reserve (FFR) and coronary flow reserve (CFR) ie FFR ≤0.80 CFR ≥2.0, FFR ≤0.80 CFR <2.0, FFR >0.80 CFR ≥2.0 and FFR >0.80 CFR <2.0. [ Time Frame: Duration of procedure in the catheterization laboratory ie 1 day ]This is primarily an observational pilot study where coronary physiology is obtained at the time of the percutaneous coronary intervention (PCI) of the target vessel.
- Change in FFR in target vessel [ Time Frame: Baseline and post PCI ]FFR will be measured pre and post PCI of target vessel
- Change in CFR in target vessel [ Time Frame: Baseline and post PCI ]CFR will be measured pre and post PCI of target vessel
- Change in index of microvascular resistance (IMR) in target vessel [ Time Frame: Baseline and post PCI ]IMR will be measured pre and post PCI of target vessel
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745821
|Contact: Lyne Stuewe||613 6967000 ext email@example.com|
|Contact: Colleen Chilton||613 6967000 ext firstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Colleen Chilton 613 6967000 ext 14646 email@example.com|
|Contact: Lyne Stuewe 613 6967000 ext 14646 firstname.lastname@example.org|
|Principal Investigator:||Aun-Yeong Chong, MD||Ottawa Heart Institute Research Corporation|