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Innate Human Collateral Supply to Different Vascular Regions

10 maggio 2016 aggiornato da: University Hospital Inselspital, Berne

Both clinical and experimental studies demonstrate the importance of the pre-existing, ie innate collateral supply in different vascular regions. Furthermore, pathophysiological considerations and experimental data imply an important role for the association of collateral function between different vascular regions.

STUDY HYPOTHESES 1. In the absence of atherosclerotic stenoses, there is a direct association between the collateral function in the coronary, renal and peripheral circulation. 2. The increase in plasma renin in response to a unilateral main renal artery balloon occlusion is inversely related to its functional collateral supply. 3. The decrease in renal vein oxygen saturation in response to a unilateral main renal artery occlusion is inversely related to its functional collateral supply.

Panoramica dello studio

Descrizione dettagliata

Background

PROTECTIVE EFFECT AND INTER-INDIVIDUAL DISTRIBUTION OF THE COLLATERAL CIRCULATION IN DIFFERENT VASCULAR REGIONS

Of all vascular regions, the collateral circulation of the heart is probably the most extensively studied since the initial studies by Fulton.1 The clinical importance of the coronary collateral circulation2 has been established by numerous investigations demonstrating a protective role of well vs. poorly grown coronary collateral arteries.

Whereas involvement of the peripheral arterial network by obstructive arterial disease is frequently asymptomatic, it is, nevertheless, relevant through the association with increased mortality and as a strong predictor of adverse cardiovascular outcomes. The clinical relevance of the collateral circulation in the lower extremities can be epitomized by the discrepancy of frequently encountered long segmental occlusions and the rare occurrence of severe ischemia or amputation. With regard to a systematic evaluation of this apparently well-collateralized region, it was, however, only very recently that assessment using a direct and quantitative method was performed.

Regarding the kidney, the collateral circulation has hitherto been subject to systematic research only in experimental studies,while data in humans are sparse and limited to angiographic assessment. While the hypertensive effect of renal arterial constriction is well-known since the seminal studies of Goldblatt in 1934, the effect of renal collaterals in this context has been neglected despite the readily apparent effects therefrom in the same experiment. The duration of the ensuing hypertension was only short in Goldblatt's experiments with dogs, an observation explained by the abating effect of efficient collaterals on renal artery constriction and consequently developing reduction of the renal ischemia. In humans, only limited and indirect data on the compensatory effect of the renal collateral circulation in the setting of renal arterial constriction exist.The ratio of selective renin concentrations sampled from the renal vein of both kidneys (affected/unaffected) is commonly used to assess the hemodynamic significance of a unilateral renal artery stenosis. Ernst et al., in 37 patients with unilateral renal stenosis, determined the (selective) renal vein renin ratio and additionally performed angiography for presence of renal collaterals( documented in 68%). Renal collaterals tended to normalize renin excretion in a kidney affected by renal artery stenosis. Indeed, 7 patients with a severe stenosis and visible renal collaterals had a normal renin ratio below the cut-off of 1.4. The clinical relevance of renal artery stenosis is underscored by its prevalence in a significant proportion of patients undergoing routine cardiac angiography.22, 23 In the above context, it is noteworthy that hypertension is not present in almost one half of patients with angiographically significant narrowing of a renal artery.

PRE-EXISTING COLLATERAL CIRCULATION AND ITS INTRA-INDIVIDUAL DISTRIBUTION As alluded to before, acute vascular occlusion in arteriosclerosis can ensue in the absence of relevant narrowing. In this situation, solely the native, pre-existing collateral extent can lessen the ischemic tissue injury. On the other hand, the gradual narrowing of a vessel allows development of large arterial anastomoses from pre-existing smaller arterioles in the process known as arteriogenesis. The notion that the pre-existing collateral extent nevertheless remains the basis for the capacity of anastomoses to enlarge is supported by an instructive experimental study by Zbinden et al.: Flow recovery after superficial femoral artery ligation correlated strikingly with the pre-existing collateral extent. Thus, mice with an already high level of pre-existing collaterals had concordantly high flow recovery, while mice with low levels of pre-existing collaterals had low flow recovery.

Given the systemic process of atherosclerosis, the preformed or innate human collateral function in the different vascular regions mentioned before is of interest. On a patient level, this relates to the intra-, as opposed to the inter-individual distribution of the collateral network. While the inter-individual distribution of collateral function in humans has been shown to vary widely also in the absence of vascular narrowings, recent experimental studies in mice have shown that innate collateral extent is shared qualitatively in different tissues. However, in humans, the association between the collateral function in different vascular regions in humans has so far not been investigated.

In conclusion, both clinical and experimental studies demonstrate the importance of the pre-existing, ie innate collateral supply in different vascular regions. Furthermore, pathophysiological considerations and experimental data imply an important role for the association of collateral function between different vascular regions.

Objective

To determine the in vivo prevalence and distribution of functional collateral supply in the coronary, renal and peripheral circulation, and the intra-individual association of collateral function between the different vascular territories. Additionally, the effect of renal collaterals on the response of the kidney to a short bout of ischemia will be investigated.

Methods

DESIGN Prospective, comparative observational study with collateral function measurements in the coronary, renal and superficial femoral artery.

PRIMARY STUDY ENDPOINT Pressure-derived collateral flow index (CFI) SECONDARY STUDY ENDPOINTS Intracoronary ECG ST segment shift during temporary coronary balloon occlusion; plasma renin concentration before, immediately and 10 minutes after main renal artery occlusion, sampled from the suprarenal inferior vena cava ; transcutaneous oxygen tension (tcpO2) as obtained during left superficial femoral artery occlusion from the left anteromedial lower leg.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

120

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Bern, Svizzera, 3010
        • Department of Cardiology, Bern University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients electively referred for coronary angiography in the context of chest pain.

Descrizione

Inclusion Criteria:

  • Age > 17 years
  • Referred for elective coronary angiography
  • Written informed consent to participate in the study

Exclusion Criteria

  • Acute coronary syndrome
  • Severe cardiac valve disease
  • Congestive heart failure NYHA III-IV
  • History of renal disease with normal renal function/ solitary kidney
  • Renal (abnormal serum creatinin level) or hepatic failure
  • Peripheral artery disease > stage I

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Coronary artery disease
With coronary artery disease
No coronary artery disease
Without coronary artery disease

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Collateral Flow index
Lasso di tempo: At baseline
At baseline

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Intracoronary ST segment elevation
Lasso di tempo: At baseline
At baseline
Transcutaneous oxygen tension (tcpO2)
Lasso di tempo: At baseline
At baseline
Plasma renin concentration
Lasso di tempo: Before, immediately after and 10 minutes after main renal artery occlusion
Before, immediately after and 10 minutes after main renal artery occlusion
Renal vein oxygen saturation
Lasso di tempo: Before, during and immediately after main renal artery occlusion
Before, during and immediately after main renal artery occlusion

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Christian Seiler, MD Prof, Department of Cardiology, Bern University Hospital, Switzerland

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2013

Completamento primario (Effettivo)

1 dicembre 2015

Completamento dello studio (Effettivo)

1 dicembre 2015

Date di iscrizione allo studio

Primo inviato

10 febbraio 2014

Primo inviato che soddisfa i criteri di controllo qualità

12 febbraio 2014

Primo Inserito (Stima)

14 febbraio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 maggio 2016

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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